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Study Objectives
This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: mil60, DRUG: Bevacizumab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* signed inform consent form(ICF)
* Aged 18-75 years, male or female
* Histologically or cytologically documented inoperable, local advanced (stage IIIB), metastatic (stage IV), or recurrent non-squamous NSCLC
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for 6 months after receiving last study treatment
Exclusion Criteria:
* Mixed non-small cell lung cancer with squamous cell carcinoma component, or small cell carcinoma
* Patients with known Anaplastic Lymphoma Kinase(ALK) or C-Ros Oncogene 1 Receptor Tyrosine Kinase (ROS1)rearrangement
* History of hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL
* Evidence of tumor invading major blood vessels on imaging
* Patients with brain metastasis, spinal cord compression or carcinomatous meningitis history
* Uncontrolled hypertension, prior history of hypertensive crisis and hypertensive encephalopathy
* Clinically significant cardiovascular disease but not limited to active infections; unstable angina; stroke or transient cerebral ischemia; myocardial infarction; congestive heart-failure; serious cardiac arrhythmia, hepatic, renal or metabolic disease requiring medication during the study
* History of radical radiotherapy to the thorax within 6 months
* Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of the study
* Recent or current treatment with aspirin or other non-steroidal anti-inflammatory drugs (NSAID) known to inhibit platelet function within 10 days prior to first dose of study treatment
* Recent or current treatment with anticoagulants or thrombolytic agent within 10 days prior to first dose of study treatment | 9,478 |
Study Objectives
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
Conditions: Conventional Chondrosarcoma
Intervention / Treatment:
DRUG: IPI-926, DRUG: Placebo Arm
Location: Netherlands, Poland, Austria, Germany, United States, Norway, Canada, Australia, France, United Kingdom, Sweden, Russian Federation, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria:
* At least 18 years of age at the time of signing informed consent.
* Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
* Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
* At least 1 radiologically measurable target lesion per RECIST 1.1.
* Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
* Life expectancy of at least 3 months
* All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug.
* Ability to adhere to the study visit schedule and all protocol requirements.
* Voluntarily signed an informed consent form.
Exclusion Criteria:
* Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
* Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
* Prior treatment with a Hedgehog pathway inhibitor
* Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
* Inadequate hematologic function defined by:
* Hemoglobin \<8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
* Inadequate hepatic function defined by:
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN).
* Total bilirubin \>1.5 x ULN (with the exception of patients with Gilbert's disease).
* Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
* Inadequate renal function defined by serum creatinine \>1.5 x ULN
* Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
* Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
* Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study. Examples include, but are not limited to sepsis and recent significant traumatic injury.
* Known human immunodeficiency virus (HIV) positivity.
* Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules.
* Pregnant or lactating women.
* Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity | 738 |
Study Objectives
The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.
Conditions: Rectal Bleeding
Intervention / Treatment:
DEVICE: Pillcam® COLON Capsule
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Positive feaecal occult bleeding test at screening
Exclusion Criteria:
* Previous gastrointestinal surgery except for appendectomy
* Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
* An ostomy
* Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
* Vomiting in connection with the bowel emptying procedure | 41,875 |
Study Objectives
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: 12 cycles of oxaliplatine based adjuvant chemotherapy, DRUG: 8 cycles of oxaliplatine based adjuvant chemotherapy
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)
Exclusion Criteria:
* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* Stage I or Stage IV | 709 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: cisplatin, DRUG: cyclophosphamide, DRUG: etoposide
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed small cell lung cancer
* Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)
* Measurable disease
* Concurrent CNS metastases allowed provided patient remains asymptomatic
* Radiotherapy or surgery for uncontrolled symptoms allowed before study entry
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
* ALT ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 2 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Concurrent corticosteroids for brain metastases allowed
Radiotherapy
* See Disease Characteristics
* Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated
* No concurrent radiotherapy
Surgery
* See Disease Characteristics | 43,337 |
Study Objectives
The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.
Conditions: Papillomavirus Infections, Warts, Condylomata Acuminata, Epidermodysplasia Verruciformis
Intervention / Treatment:
OTHER: PURELL VF481, OTHER: Placebo Solution
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Patients with 2+ warts being seen at a Dermatologist's office
* 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers
* Warts must have been present for at least 2 months
* Wart size must be between 2 mm-15 mm in diameter
* Participants must be in good general health
* Participants must be able to speak and read in English.
* Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.
* Subjects must be able to understand and execute the instructions presented in pictorial form.
Exclusion Criteria:
* Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).
* Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.
* Known allergies to common topical antimicrobials or the individual ingredients in either test product.
* Participation in a clinical study in the past 7 days or participation in another clinical study
* Unwillingness to perform requirements of the study
* Any medical condition that should preclude participation in the study, at the discretion of the physician
* Missed ≥ 6 of the treatments in a 4 week study period | 44,361 |
Study Objectives
Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Supportive Care
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Women with metastatic breast cancer
* ECOG performance score ≤3.
* English Speaking
* With sufficient vision/hearing or family support
* Willingness to be randomized
Exclusion Criteria:
* Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
* Patients who are receiving any other behavioral intervention | 17,781 |
Study Objectives
This randomized clinical trial studies epidural anesthesia within an enhanced recovery pathway (ERP) in reducing pain in patients undergoing gynecologic surgery. An epidural analgesia (pain relief) is a small tube placed in the lower back that numbs the nerves and stops the feeling of pain. It stays in place for several days after surgery and may be helpful for pain control in patients with gynecologic cancer after surgery. ERP is a set of specific steps used before, during, and after surgery by health care providers to care for patients after surgery. ERPs include patient education, not using laxatives before surgery, increasing activity after surgery, and scheduled use of medications for pain and nausea. Giving epidural anesthesia as part of an ERP may improve pain control in patients undergoing gynecologic surgery.
Conditions: Intraoperative Complication, Malignant Female Reproductive System Neoplasm, Pain
Intervention / Treatment:
DRUG: Epidural analgesia, OTHER: Intraoperative Complication Management and Prevention, PROCEDURE: Pain Therapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients undergoing gynecologic surgery via midline vertical laparotomy at University of Wisconsin Hospital and Clinics (UWHC)
* Patients must be English speaking
* Patients must have the ability to understand visual and verbal pain scales
* Patients must be eligible for epidural placement
Exclusion Criteria:
* Known allergy to local anesthetics
* Known history of chronic pain disorders and/or chronic opioid use defined as \> 10 mg of oral (PO) morphine or equivalent used daily for at least 30 days prior to enrollment
* Patient is a prisoner or incarcerated
* Significant liver disease that would inhibit prescription of opioids
* Significant kidney disease that would inhibit administration of gabapentin
* Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists
* Patient is pregnant
* Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study | 5,098 |
Study Objectives
This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.
Conditions: Dupuytren's Disease
Intervention / Treatment:
DRUG: collagenase injection, PROCEDURE: limited palmar fasciectomy
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
1. Canadian Citizen
2. 18 years of age or older
3. Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at least 1 finger (not the thumb)
4. Demonstrated inability to simultaneously place the affected finger and palm flat on a table
5. Able to understand and communicate in English
Exclusion Criteria:
1. Previous treatment of the primary joint within 90 days of study inclusion
2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel release, stenosing tenosynovitis release)
3. Persistent extension deficit from a previous surgery of the same digit
4. Any chronic muscular or neuromuscular disorder affecting wrist or hand
5. Patient generally unfit for surgery
6. Patient with specific treatment preference
7. Bleeding disorder or recent stroke
8. Allergy to collagenase
9. Collagenase treatment or treatment with any investigational drug within 30 days of study inclusion
10. Use of a tetracycline derivative within 14 days of first dose of study drug (because tetracycline derivatives may inhibit the collagenolytic activity of mammalian collagenase homologs \[i.e., matrix metalloproteinases\])
11. Pregnant or breast feeding patients
12. Patients who do not have insurance coverage for collagenase injections
13. Patients who are unable to provide informed consent or are unable to complete quality of life questionnaires due to mental capacity or neuro-psychological problems. | 42,943 |
Study Objectives
The purpose of this study is to see how the brain re-learns to control the larynx in speaking and swallowing when undergoing surgical rehabilitation in the form of either thyroplasty or vocal fold augmentation for unilateral vocal cord paralysis. What is needed is information on how the brain re-learns to control speaking and swallowing so that we can eventually learn how to help patients re-learn faster after their procedure. Functional Magnetic Resonance Imaging (or fMRI) will allow us to image your brain as you speak and swallow. We will produce "brain maps" for speaking, swallowing and hand movements.
Conditions: Intrathoracic Malignancies, Unilateral Vocal Cord Paralysis
Intervention / Treatment:
OTHER: voice evaluation and fMRI, OTHER: undergo voice evaluation and fMRI prior
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing.
* Inclusion criteria for the healthy subjects:
* From age 18-85
Exclusion Criteria:
* for the UVCP patients includes the following:
* History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
* History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.
* History of previous moderate to severe traumatic brain injury.
* History of significant cardiovascular, gastrointestinal or renal disease (e.g. myocardial infarction within the previous 12 months, significant vaso-occlusive disease, severe or advanced asthma, or renal compromise)
* History of achalasia
* History of dysphagia, odynophagia, or aphasia unrelated to present illness.
* History of significant claustrophobic reactions.
* Standard contraindications to MR examinations (e.g. implanted stimulators, pregnancy).
Exclusion criteria for the healthy subjects includes the following:
* All of the conditions listed for the UVCP patients.
* Significant surgery or previous radiation therapy to the head and neck.
* History of other neoplasms involving the brain, head and neck, or gastrointestinal system. | 18,634 |
Study Objectives
To evaluate the increase in Overall Response Rate (ORR) in the pembrolizumab alone arm compared to the pembrolizumab after SBRT arm at 12 weeks
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: pembrolizumab, RADIATION: Stereotactic Body Radiation Therapy
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Be willing and able to provide written informed consent/assent for the trial.
2. Be ≥ 18 years of age on day of signing informed consent.
3. Have measurable disease based on RECIST 1.1.
4. Must provide newly obtained tissue from a core or excisional biopsy of a tumor lesion and are willing to have a second biopsy performed form any non-irradiated lesion after the radiation and immune-modulating treatment.
5. Have a performance status of 0 or 1 on the ECOG Performance Scale.
6. Stage IV NSCLC; treated with at least 1 regimen of chemotherapy.
7. Have at least 2 separate (metastatic) lesions of which one is amenable for irradiation with a size of \< 5 cm.
8. Demonstrate adequate organ function:
Absolute neutrophil count (ANC) ≥1,500 /mcL; Platelets ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L; Serum creatinine ≤1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥50 mL/min for subject with creatinine levels \> 1.5 X institutional ULN; Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases; International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
All screening labs should be performed within 10 days of treatment initiation.
9. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
10. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
11. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
3. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
4. Has had prior chemotherapy or targeted small molecule therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subjects received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
5. Have had previous radical radiation to any tumor site within 6 months prior to study Day 1.
6. Have known but untreated driver mutations of the EGFR gene or ALK translocation.
7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. 8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least six weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.
9. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study.
10. Has evidence of symptomatic interstitial lung disease or an active, non-infectious pneumonitis.
11. Has an active infection requiring systemic therapy. 12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
14. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
15. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
18. Has received a live vaccine within 30 days prior to the first dose of trial treatment.
19. Has had major surgery or major blood transfusions (\>3 packed cells) in the past 3 months. | 24,270 |
Study Objectives
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.
Conditions: Head and Neck Cancer
Intervention / Treatment:
GENETIC: cytogenetic analysis, GENETIC: gene expression analysis, GENETIC: mutation analysis, GENETIC: polymerase chain reaction, OTHER: immunohistochemistry staining method, OTHER: laboratory biomarker analysis
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository
* Sufficient biological material collected to perform study tests
* Historical material available from excess tissues at the Vanderbilt Pathology Department
Exclusion Criteria:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified | 16,476 |
Study Objectives
The purpose of this study is to evaluate the ability of two different fixed doses of pegfilgrastim (6mg and 12mg) and a by-weight dose of filgrastim (5ug/kg/day) for the mobilisation and collection of PBPCs for autologous transplantation after chemotherapy.
Conditions: Non-Hodgkin's Lymphoma
Intervention / Treatment:
DRUG: pegfilgrastim, DRUG: filgrastim
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria: - Subjects with non-Hodgkin's lymphoma (NHL) who are considered to be suitable candidates for autologous PBPC transplantation per institution guidelines - ECOG 0-2 inclusive - ANC greater than 1.5 x 10\^9/L; PLT greater than 100 x 10\^9/L Exclusion Criteria: - More than one line (regimen) of previous chemotherapy treatment and more than 2 cycles of any premobilisation salvage chemotherapy prior to enrolment. Patients were also to be excluded from the study if they had received any salvage chemotherapy containing the following agents: procarbazine, nitrogen mustard, nitrosoureas (including BCNU), melphalan and fludarabine. - Previous bone marrow or PBPC transplant - Greater than 20% bone marrow involvement of the disease at time of screening, as demonstrated by biopsy - Prior total nodal irradiation or any radiotherapy in the past 4 weeks - Serum creatinine greater than 1.5 x upper limit of institutional normal range - Total serum bilirubin greater than 2 x upper limit of institutional normal range - Current diagnosis of splenomegaly not related to lymphoma - History of prior malignancy, except for lymphoma, curatively treated basal cell carcinoma, squamous cell carcinoma, in-situ cervical carcinoma or a surgically cured malignancy - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Significant non-malignant disease, including documented HIV infection, uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg), unstable angina, congestive heart failure (greater than NY Heart Association Class II), poorly controlled diabetes, coronary angioplasty within 6 months, uncontrolled atrial or ventricular cardiac arrhythmias, or active hepatitis C - Haematopoietic growth factors administered within 1 week of study entry. If growth factor support was given during previous chemotherapy cycles, WBC less than 15.0 x 10\^9/L was required at enrolment - Treatment with Interferon® during the last 3 months - Known hypersensitivity to E. coli-derived pharmaceutical products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase) - Subject had previously been randomised into this study | 12,263 |
Study Objectives
This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up, according to the clinical guidelines. The diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.
Conditions: Thyroid Nodule, Thyroid Neoplasm, Thyroid Cancer
Intervention / Treatment:
Location: Poland
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* a diagnosis of thyroid nodule
* considerable chance for surgical procedure following biopsy result
* patient's consent for collection of material during routine fine needle aspiration biopsy
Exclusion Criteria:
* age below 18 years
* the presence of contraindications that make surgical treatment impossible
* prior diagnosis of thyroid cancer
* antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose | 13,064 |
Study Objectives
The safety and efficacy of ω-3 fatty acid in patients with liver cancer followed hepatectomy is not known. This study provided evidences that ω-3 fatty acid-based parenteral nutrition improved postoperative recovery for cirrhotic patients with liver cancer underwent hepatectomy..
Conditions: Liver Cancer, Cirrhosis
Intervention / Treatment:
DRUG: Omega-3 Fatty Acid-Based Parenteral Nutrition, DRUG: Structolipid
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria:
* The cirrhotic malnourished patients who were diagnosed as liver cancer preoperatively and underwent hepatectomy were consecutively enrolled.
Exclusion Criteria:
* Contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, Child-Pugh Score C, indocyanine green retention rate at 15min (ICGR15)\>30%(12), serum hepatitis B virus (HBV)-DNA\>126 copies/ml and serum alanine aminotransferase (ALT) \> 2×ULN, serum triglycerides\>2.0 mmol/L, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause
* Pregnancy
* Age of\<18y or\>75y
* Performed intraoperative ablation
* Unresectable tumor during operation
* Allergic reactions against fish or egg proteins | 15,460 |
Study Objectives
This research study is a pilot study, which is the first time investigators are examining the effect of light alcohol consumption on sex hormones among postmenopausal women with estrogen receptor-positive (ER+) breast cancer taking an aromatase inhibitor
The names of the study exposures involved in this study are:
* White wine
* White grape juice
Conditions: ER+ Breast Cancer, Breast Cancer, Aromatase Inhibitors
Intervention / Treatment:
OTHER: White Wine, OTHER: Grape Juice
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: SINGLE | Inclusion Criteria:
* ER+ breast cancer
* Female sex at birth
* Postmenopausal, either natural or induced
* Self-reported consumption of at least one alcoholic drink per week but not more than one serving per day
* Currently prescribed aromatase inhibitors including anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®)
* Documented liver function test results below 1.5X the upper limit of normal within 12 months of screening
Exclusion Criteria:
* Self-reported consumption of more than one drink per day, a previous or current history of alcohol abuse based on standard questionnaires (AUDIT≥8), or consumption of more than 4 or more drinks in one day within the last 6 months
* Currently undergoing cytotoxic chemotherapy or radiation or planned in the next two months
* Any surgery planned in the next two months
* Alcohol flushing syndrome
* Current use of any pharmaceutical agent contraindicated with alcohol, including warfarin, dual antiplatelet therapy, and metronidazole
* Hemoglobin A1c\>8% or a fasting glucose result above 180 mg/dL within 6 months of screening
* Unable to speak or understand English
* Unable to understand and provide informed consent, as judged by the study team | 26,444 |
Study Objectives
There is no clear standard of care for metastatic stomach or esophageal cancer in the United States. The purpose of this research study is to determine the differences between two regimens of chemotherapy; Arm A: PCA (Cisplatin, Irinotecan and Bevacizumab) and Arm B: TPCA (Docetaxel, Cisplatin, Irinotecan and Bevacizumab). Docetaxel, Cisplatin, and Irinotecan are traditional chemotherapy drugs. Bevacizumab is an antibody (a protein that attacks a foreign substance in the body). Bevacizumab is believed to stop the formation of new blood vessels that carry nutrients to tumors. Both of the chemotherapy regimens (PCA and TPCA) have been studied in patients with esophageal and gastric cancer, and we are trying to determine if one regimen will keep your cancer from growing and improve how long you can live.
Conditions: Esophageal Cancer, Gastric Cancer, Stomach Cancer
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Cisplatin, DRUG: Irinotecan, DEVICE: Docetaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable disease is not required.
* 18 years of age or older
* ECOG Performance Status=2
* Life expectancy of 12 weeks or greater
* Adequate bone marrow, renal and liver function as outlined in the protocol.
* Men and women of childbearing potential must use adequate contraception
Exclusion Criteria:
* Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol).
* Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor
* Known history of allergy or hypersensitivity to Chinese hamster ovary products, polysorbate 80, or any of the study drugs
* Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1. Concurrent use of herbal medications or other alternative therapies
* Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1
* Palliative radiation to 25% or less of bone marrow, must be completed \> 2 weeks prior to day 1, palliative radiation to \> 25% of bone marrow, must be completed \> 4 weeks prior to day 1
* Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the past six months
* Inadequately controlled hypertension (defined as systolic blood pressure of \>150mmHg and/or diastolic blood pressure of \> 100mmHg). Initiation of antihypertensive medication is recommended, however adequate control of blood pressure must be documented prior to C1 D1
* No history of prior hypertensive crisis or hypertensive encephalopathy
* NYHA Grade II or greater congestive heart failure
* Clinically significant peripheral vascular disease
* Active bleeding from primary tumor
* Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis, portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on therapeutic anticoagulation may be enrolled provided they have been clinically stable on anticoagulation for a least 2 weeks prior to C1 D1.
* Uncontrolled serious medical or psychiatric illness
* Uncontrolled diarrhea
* Peripheral neuropathy
* No known brain or other CNS metastasis by history or clinical examination
* Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years
* Urine protein:creatinine ratio 1.0 or greater at screening
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess with 6 months of C1 D1
* Serious, non-healing wound, ulcer or bone fracture
* Pregnant or breast feeding
* Inability to comply with study and/or follow-up procedures
* History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or other serious chronic infection | 21,215 |
Study Objectives
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Conditions: Ewing Sarcoma, Gastrointestinal Tumor, Germ Cell Tumor, Hepatic Tumor, Lymphoma, Wilms Tumor, Rhabdoid Tumor, Clear Cell Carcinoma, Renal Cell Carcinoma, Melanoma, Neuroblastoma, Rhabdomyosarcoma, Non-rhabdomyosarcoma
Intervention / Treatment:
DRUG: alemtuzumab, DRUG: fludarabine, DRUG: sirolimus, DRUG: Busulfan, DRUG: melphalan, BIOLOGICAL: stem cells, DEVICE: CliniMACS
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria - Transplant Recipients:
* At least 2 years of age and less than or equal to 21 years of age.
* Histologically confirmed solid tumor or lymphoma at original diagnosis:
* Ewing Sarcoma Family of Tumors (ESFT)
* Gastrointestinal tumors
* Germ Cell tumors
* Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma)
* Lymphoma (including Hodgkin and non-Hodgkin lymphoma)
* Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma)
* Melanoma
* Neuroblastoma
* Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma)
* Malignancy has no reasonable expectation of cure with available alternative salvage therapy.
* Has a suitable human leukocyte antigen (HLA) haploidentical donor available.
* At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
* Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI.
* Shortening fraction greater than or equal to 25%.
* Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2.
* Pulse oximetry greater than or equal to 92% on room air
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range.
* Direct bilirubin less than or equal to 3.0 mg/dL.
* Karnofsky or Lansky performance score of greater than or equal to 50.
Exclusion Criteria - Transplant Recipients:
* Newly diagnosed patients with no prior attempt at curative therapy.
* Any primary or active central nervous system (CNS) malignancy, including metastatic disease.
* Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy.
* Prior allogeneic hematopoietic stem cell transplant.
* Prior autologous stem cell transplant within previous 3 months.
* Allergy to murine products or positive human anti-mouse antibody (HAMA).
* (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
* (Female only) Breast feeding.
Inclusion Criteria - Donors:
* At least 18 years of age.
* Partially HLA matched family member.
* Human immunodeficiency virus (HIV) negative.
Exclusion Criteria - Donors:
* (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
* (Female only) Breast feeding. | 37,450 |
Study Objectives
Background:
NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3).
NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4).
Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase inhibitors.
In the phase I trial conducted at the National Cancer Institute (NCI), responses were observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell lymphoma.
Objectives:
In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall response rate, complete response rate and duration of response.
In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are overall response rate and complete response rate.
To evaluate the tolerability of depsipeptide with extended cycles of therapy.
Eligibility:
Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other peripheral T-cell lymphomas are eligible.
Design:
Depsipeptide will be administered at 14 mg/m\^2, over 4 hours on days 1, 8 and 15.
This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients with cutaneous T cell lymphoma who have received vorinostat.
Dose may be adjusted based on toxicities.
Conditions: Cutaneous T Cell Lymphoma, Peripheral T Cell Lymphoma
Intervention / Treatment:
DRUG: Romidepsin
Location: Australia, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | * INCLUSION CRITERIA:
Based on the Inclusion Criteria outlined below, patients will accrue to one of the cohorts of the trial.
Cohort- chemotherapy regimens allowed. Cohort Status
Cohort 1
Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome)-2 or fewer. Closed to accrual
Cohort 2
Peripheral T-cell Lymphoma, unspecified, or Anaplastic large cell lymphoma (T and null cell) Primary Cutaneous Type -2 or fewer. Open and accruing
Cohort 3
Cutaneous T-cell Lymphomas or Peripheral T-cell Lymphoma-More than 2. Closed to accrual
Cohort 4
Other Mature T cell Lymphomas-Any number. Open and accruing
Cohort 5
Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome)-2 or fewer-Cohort 5 is a replicate cohort, identical to #1
Cohort 6
Peripheral T-cell Lymphoma (PTCL), unspecified, or Anaplastic large cell lymphoma (T and null cell) Primary Cutaneous Type-More than 2. Patients with PTCL in cohort 3 migrated to this cohort
Cohort 7
Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome) Prior vorinostat required-Any number
Patients with cutaneous T-cell lymphoma \[CTCL (mycosis fungoides or Sezary syndrome) stage IB to IVB are eligible. Patients with stage IB and IIA should be refractory to, intolerant to, or have reached a six-month or longer response plateau on at least two prior therapies from the following list: psoralen plus ultraviolet A irradiation (PUVA), ultraviolet B (UVB), electron beam therapy (EBT), photophoresis, interferon, systemic cytotoxic chemotherapy, topical nitrogen mustard, or topical carmustine (BCNU). One qualifying prior treatment must have been topical nitrogen mustard, topical carmustine or a phototherapy (UVB, PUVA or EBT). Topical steroids, systemic retinoids or biologicals do not qualify. Patients with stage IB or IIA who are not candidates for topical nitrogen mustard, topical carmustine or phototherapy (UVB, PUVA or EBT) are eligible for enrollment. Patients may not have received more than two systemic cytotoxic chemotherapy regimens. Steroids, retinoids, and biologic agents, will not be considered as systemic cytotoxic chemotherapy. Radiolabeled monoclonal antibody therapy is considered equivalent to a systemic cytotoxic chemotherapy regimen and must be counted toward the two prior systemic cytotoxic regimens. Patients with stage IIB-IVB who have had no more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible. There is no restriction regarding number of prior topical therapies, skin irradiation, or non-cytotoxic systemic therapies (i.e. PUVA, retinoids or biologic, with the exception of radiolabeled monoclonal antibody therapy) in this patient group. After 24 patients were enrolled in this arm, the arm was closed, and a replicate arm constituted of this same patient population was opened (Cohort 5).
Patients with peripheral T-cell lymphoma (PTCL), unspecified, or anaplastic large cell lymphoma, T and null cell, primary cutaneous type, as defined by the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification (16-18), who have experienced disease progression after receiving prior standard treatment and who have had no more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible.
Patients with cutaneous T cell lymphoma (Mycosis fungoides or Sezary Syndrome) or peripheral T cell lymphoma as defined above who have received more than 2 prior systemic therapies and who have experienced disease progression will be included in a third and independent arm. This arm of the protocol was closed to accrual for CTCL with Amendment H.
Patients with mature T cell lymphomas not included above will be enrolled in a fourth arm. These include but are not exclusively limited to: Enteropathy-type T cell lymphoma; Hepatosplenic T-cell lymphoma; Subcutaneous panniculitis-like T cell lymphoma; Angioimmunoblastic T-cell lymphoma; Anaplastic large cell lymphoma. Patients must have experienced disease progression after receiving prior standard treatment. There will be no limit on the number of prior regimens. Primitive T cell neoplasms and T cell leukemias will not be enrolled.
Patients with peripheral T-cell lymphoma, unspecified, or anaplastic large cell lymphoma, T and null cell, primary cutaneous type, as defined by the REAL/WHO classification (16-18), who have experienced disease progression after receiving prior standard treatment and who have had more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible for enrollment to a sixth arm of the trial.
Patients with cutaneous T cell lymphoma (Mycosis fungoides or Sezary Syndrome) or peripheral T cell lymphoma as defined in #1 who have received any number of prior systemic therapies and who have previously been treated with vorinostat will be included in a third and independent arm. Patients can be enrolled in this arm if they received prior vorinostat and experienced disease progression, subsequent relapse, or had to discontinue to agent due to toxicity.
Disease that is measurable by radiographic imaging, assessing skin lesions, or by quantitating Sezary cell count.
Patients must:
be age greater than or equal to 18 years
have a performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
have no serious or intercurrent illness and have a life expectancy of greater than 12 weeks
give written informed consent
female patients of childbearing potential must have a negative pregnancy test within 4 weeks and must use effective contraception
sexually active males must use effective contraception
Laboratory values (performed less than or equal to 14 days prior to registration):
absolute neutrophil count greater than or equal to 1000/microliter, platelets greater than or equal to l00,000/microliter, bilirubin (total and direct) less than or equal to 1.5x upper limit of normal, and aspartate aminotransferase (AST) less than or equal to 3x upper limit of normal, unless impairment is due to organ involvement by lymphoma, creatinine less than or equal to 1.5x upper limit of normal, or documented creatinine clearance of greater than or equal to 60mL/min
Cardiac studies (performed within 4 weeks of registration):
Ejection fraction of greater than 50% by Echocardiogram or Cardiac magnetic resonance imaging (MRI), or greater than or equal to 45% by multi-gated acquisition scan (MUGA) Scan.
A stable dose (greater than 1 month) of corticosteroids administered for symptom management will not preclude enrollment. Tapering will be initiated following administration of depsipeptide.
EXCLUSION CRITERIA:
Patients with unconfirmed diagnosis, or with B-cell lymphomas will be excluded.
Prior or concurrent malignancies that have not been curatively treated.
Known central nervous system (CNS) lymphoma.
Chemotherapy within 4 weeks, 6 weeks for nitrosoureas or mitomycin C.
Biologics, Immunotherapy within 2 weeks.
Human Immunodeficiency virus (HIV) seropositivity.
Pregnant or breast-feeding patients.
Major surgery within 21 days.
Uncontrolled infection or uncontrolled medical illness.
Patients having received prior histone deacetylase (HDAC) inhibitor therapy for T cell lymphoma will be excluded except for patients eligible to enroll in cohort 7.
Patients with the following cardiac risk factors will be excluded from the study:
Patients with known cardiac abnormalities such as:
Congenital long QT syndrome
Corrected QT interval (QTc) interval greater than 480 milliseconds
Patients who have had a myocardial infarction within 12 months of study entry.
Patients who have active coronary artery disease as, e.g. angina as defined by Canadian Class II-IV
Patients with an electrocardiography (ECG) recorded at screening showing evidence of cardiac ischemia (ST depression of greater than or equal to 2 mm).
Any patient in whom coronary artery disease is suspected should be referred for a cardiology consultation and if active myocardial ischemia is demonstrated the patient should be excluded. If a noninvasive imaging study is equivocal, it may be necessary to proceed to coronary angiography.
Patients with congestive heart failure that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction less than 45% by MUGA scan or less than 50% by echocardiogram and/or MRI.
Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD). Patients with a history of arrhythmia should have Holter monitoring and evaluation by cardiology.
Patients with dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above). Patients with left ventricular hypertrophy should be discussed with the Principal Investigator or Study Chairman.
Patients with uncontrolled hypertension, i.e., systolic blood pressure (SBP) greater than or equal to 160 mm Hg or diastolic blood pressure (DBP) greater than or equal to 95 mm Hg.
Patients with cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker. Patients in whom digitalis cannot be discontinued are excluded from study.
Patients with Mobitz II second degree heart block who do not have a pacemaker. Patients with first degree or Mobitz I second degree heart block, bradyarrhythmias or sick sinus syndrome require Holter monitoring and evaluation by cardiology.
Patients with other cardiac disease may be excluded at the discretion of the principal investigator (PI) following consultation with cardiology. | 40,020 |
Study Objectives
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
Conditions: Breast Neoplasms
Intervention / Treatment:
DRUG: Lapatinib, DRUG: Letrozole, DRUG: Placebo
Location: Argentina, Korea, Republic of, Pakistan, Turkey, South Africa, Colombia, New Zealand, Australia, Spain, France, Czechia, Tunisia, Mexico, Chile, Netherlands, Hungary, Germany, United States, Croatia, Canada, United Kingdom, Russian Federation, Italy, Peru, Poland, Brazil, Denmark, Bulgaria, Ireland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Key inclusion criteria
1. Signed informed consent;
2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;
* Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
* If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
3. Tumors that were ER+ and/or PgR+;
4. Post-menopausal female subjects ≥ 18 years of age.
5. ECOG Performance Status of 0 or 1;
6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (\>12 months) to the first dose of randomized therapy.
8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.
Key exclusion criteria:
1. Pre-menopausal, pregnant, or lactating;
2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;
4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. | 44,075 |
Study Objectives
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.
Conditions: Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
Intervention / Treatment:
COMBINATION_PRODUCT: IC2000 and SPY-PHI, COMBINATION_PRODUCT: Tc-99m radioactive colloid and Gamma Probe
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Be 18 years of age or older
2. Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1\*, N0, M0), IB ((T0, N1mi, M0) or T1\*, N1mi, M0)) or Stage IIA (T0, N1\*\*M0, or T1, N1\*\*, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
Where:
* Tis = Ductal carcinoma in situ
* T0 = No evidence of primary tumor
* T1 = Tumor ≤ 20 mm in greatest diameter
* T1\* = Includes T1mi
* T2 = Tumor \>20 mm but ≤ 50 mm in greatest diameter
* N0 = No regional lymph node metastasisq1'
* N1 = Metastasis to movable ipsilateral level I, II axillary LNs
* N1\*\* = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
* mi = Micro-metastasis
* M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
* M0= No evidence of metastasis
* mi= Micrometastasis
3. Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
4. Subjects with negative metastatic involvement (M0)
5. Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
6. Have signed an approved informed consent form for the study
7. Be willing to comply with the protocol
Exclusion Criteria:
1. Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
2. Advanced breast cancer subjects with stage IIB, III and IV
3. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
4. Subjects who have participated in another investigational study within 30 days prior to surgery
5. Pregnant or lactating subject
6. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for | 22,526 |
Study Objectives
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor.
Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including graft versus host disease (GVHD) and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection.
This research project will investigate the use of particular pre-transplant conditioning regimen (chemotherapy, antibodies and total body irradiation) followed by a stem cell infusion from a "mismatched" family member donor. Once these stem cells are obtained they will be highly purified in an effort to remove T cells using the investigational CliniMACS stem cell selection device. The primary goal of this study will be to determine the rate of neutrophil and platelet engraftment, as well as the degree and rate of immune reconstitution in the first 100 days posttransplant for patients who receive this study treatment. Researchers will also study ways to decrease complications that may occur with a transplant from a genetically mismatched family donor.
Conditions: Leukemia, Acute Lymphocytic (ALL), Leukemia, Myeloid, Acute(AML), Leukemia, Myeloid, Chronic(CML), Juvenile Myelomonocytic Leukemia(JMML), Hemoglobinuria, Paroxysmal Nocturnal (PNH), Lymphoma, Non-Hodgkin (NHL), Myelodysplastic Syndrome (MDS)
Intervention / Treatment:
DEVICE: Miltenyi Biotec CliniMACS, PROCEDURE: Stem Cell Transplantation, DRUG: TBI, systemic chemotherapy and antibodies as follows:
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Lacking a HLA-identical sibling or unrelated donor matched at 6 HLA loci formally requested within an approximate 90 day period from search initiation and who has a mismatched family member donor available
* At least 2 and less than or equal to 21 years of age
* Must have one of the following diagnosis:
* Acute lymphoid leukemia (ALL) in second, third, or subsequent remission.
* ALL in first remission but high risk for relapse.
* Acute myeloid leukemia (AML) in relapse or remission.
* Secondary AML / MDS
* Chronic myeloid leukemia (CML)
* Juvenile myelomonocytic leukemia (JMML).
* Myelodysplastic syndrome (MDS).
* Paroxysmal nocturnal hemoglobinuria (PNH)
* Non-Hodgkin lymphoma in second or subsequent CR
* Patients with a shortening fraction ≥ 25%
* Patients with a creatinine clearance ≥ 40cc/min/1.73m\^2
* Patients with FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air
* Patients with direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L
* Patients with a Karnofsky or Lansky (age dependent) performance score of ≥ 70
* Mismatched family member donor is available, HIV negative and ≥ 18 years of age
Exclusion Criteria:
* Patients who have received a previous hematopoietic stem cell allograft
* Patients with a known allergy to rabbit or murine products
* Patients with isolated CNS, testicular or other isolated extramedullary site of relapse | 6,824 |
Study Objectives
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Conditions: Prostatic Neoplasms
Intervention / Treatment:
DRUG: Radium-223 dichloride (Xofigo, BAY88-8223), DRUG: Matching placebo (normal saline), DRUG: Abiraterone, DRUG: Prednisone/Prednisolone
Location: Sweden, Singapore, Norway, Israel, Australia, Spain, France, Netherlands, Germany, United States, Canada, United Kingdom, Russian Federation, Poland, Italy, Finland, Belgium, Japan, Brazil
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Male subjects of age ≥ 18 years
* Prostate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
* Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis
* Asymptomatic or mildly symptomatic prostate cancer
* Subjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment
* Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)
* Eastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1
Exclusion Criteria:
* Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
* Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily
* Pathological finding consistent with small cell carcinoma of the prostate
* History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
* History of or known brain metastasis
* Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
* Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
* Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
* Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization. | 35,962 |
Study Objectives
The investigators planned this study to Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy : Extra blood sample collection during routine blood sampling.
Conditions: Gastric Cancer
Intervention / Treatment:
Location: Korea, Republic of
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients older than 20 years
* Patients with histologically confirmed metastatic gastrointestinal cancer, genitourinary cancer , rare cancer with treated any anti-cancer therapy
* Written informed consent form
Exclusion Criteria:
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety. | 38,710 |
Study Objectives
Genistein is a natural product found in soy beans; its consumption has been associated with a low incidence of metastatic prostate cancer. Genistein is a known protein-tyrosine kinase inhibitor, and in preclinical studies it has been shown to increase cell adhesion. Increases in cell adhesion in vivo would phenotypically reverse the first step in the metastatic cascade, potentially preventing metastasis formation, and is consistent with epidemiologic findings. This study seeks to determine the pharmacokinetics of genistein in humans by administering a single dose of genistein and performing a pharmacokinetic analysis. Patients will be treated with two formulations of genistein (a 43% genistein preparation or a 90% preparation). This is a phase I study, and patients will be treated on one of three dosing levels. Patients will be randomly assigned to receive one formulation first, followed by a washout period, and will then receive the second preparation (i.e. a randomized cross over design). Information from this study will be used to optimally design a multiple dose study wherein patients will be treated for longer periods of time.
Conditions: Cancer
Intervention / Treatment:
DRUG: Genistein
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | Must be 18 years old or greater.
ECOG performance status of 0-1.
Individuals without a history of cancer are eligible, as are those with a history of cancer. Individuals with a history of cancer (excluding non-melanomatous skin cancer ) will need to submit their pathology slides for review in the Laboratory of Pathology, NCI.
Must be able to understand and give informed consent.
Life expectancy greater than 6 months.
Hgb greater than or equal to 8.0gm/dl, platelets greater than or equal to 100,000/microliters, ANC greater than or equal to 1000/microliters, creatinine less than or equal to 2.0/mg/dl, SGPT and SGOT less than or equal to 147 and 168 U/L, total bilirubin less than or equal to 2 mg/dl (patients with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis).
No history of breast cancer.
No pregnant or breast feeding subjects.
Must not be HIV positive.
No history of venous thrombosis within the past year.
No medical conditions, which, in the opinion of the investigators would jeopardize either the patient or the integrity of the data obtained.
No patients who are currently receiving active therapy for neoplastic disorders. However, patients with prostate cancer who are on an LHRH agonist (e.g., Lupron or Zoladex), or who have undergone surgical castration, are eligible for study.
No patients who are on estrogen therapy.
No patients taking hormonal forms of contraception.
No patients with a known soy intolerance. | 3,116 |
Study Objectives
A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291 administered orally once daily in Chinese patients with locally advanced or metastatic non small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent.
2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Conditions: Carcinoma, Non-Small-Cell Lung With EGFR Mutation Positive
Intervention / Treatment:
DRUG: AZD9291 40 mg, DRUG: AZD9291 80 mg
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: OTHER
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Provision informed consent
2. Aged at least 18 years
3. Histological or cytological confirmation diagnosis of NSCLC
4. Locally advanced or metastatic NSCLC
5. Radiological documentation of disease progression while on a previous continuous treatment with an approved EGFR TKI. In addition other lines of therapy may have been given
* Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q)
6. World Health Organisation (WHO) performance status 0-1
7. At least one lesion suitable for accurate repeated measurements
8. Females
* Child bearing potential : should not be breast feeding, use adequate contraceptive measures for female patients with child-bearing potential, OR
* Have evidence of non-child-bearing potential that meet one of the following criteria at screening:
* Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
* Women below 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
9. Male patients should be willing to use barrier contraception ie, condoms
Exclusion Criteria:
1. Treatment with any of the following (prior to first dose of study treatment)
* Treatment with an EGFR TKI within 8 days
* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days
* Previous treatment with AZD9291, or a Thr790Met (T790M) directed EGFR TKIs
* Major surgery (excluding placement of vascular access) within 4 weeks
* Radiotherapy :
* Within 1 week if limited field of radiation for palliation of the first dose of study treatment
* Within 4 weeks if receiving radiation to more than 30% of the bone marrow or with a wide field of radiation
* Patients currently receiving (or unable to stop use at least 1 week) medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4)
* Treatment with an investigational drug within five half-lives of the compound
2. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy
3. Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment
4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
5. Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derivedQTc value
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, P wave to R wave (PR) interval \>250 msec
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long (Q-T interval) QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
6. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease 7, Inadequate bone marrow reserve or organs function as demonstrated by any of the following laboratory values:
* Absolute neutrophil count \<1.5x109/L
* Platelet count \<100x109/L
* Hemoglobin \<90 g/L
* Alanine aminotransferase \>2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases
* Aspartate aminotransferase \>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases
* Total bilirubin \>1.5 times ULN if no liver metastases or \>3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
* Creatinine \>1.5 times ULN concurrent with creatinine
8, Clearance \<50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is \>1.5 times ULN Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291 9, History of hypersensitivity to active or inactive excipients of AZD9291 or drugs with a similar chemical structure or class to AZD9291 10, Women who are breast feeding 11, Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the study site) 12, Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements | 14,883 |
Study Objectives
The goal of this clinical research study is to find out if there is a link between insulin resistance (or pre-diabetes) and endometrial cancer.
Primary Objective:
1. To determine the association between insulin resistance and endometrial cancer in women in Harris County, Texas. 2. To assess the effect of body mass index (BMI) on the association between insulin resistance and endometrial cancer.
Secondary Objectives:
1. To explore the association between polycystic ovarian syndrome (PCOS) and endometrial cancer.
2. To assess the relationship between known reproductive risk factors, menstrual risk factors, family history and endometrial cancer.
3. To explore the molecular changes associated with insulin resistance and PCOS on normal endometrium and tumor tissue.
Conditions: Endometrial Cancer
Intervention / Treatment:
BEHAVIORAL: Questionnaire
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Women with histologically confirmed primary endometrial cancer, who will consent to be enrolled in the study no later than 12 weeks after their primary treatment. All stages, grades and histologic subtypes will be eligible.
2. Women who reside in Harris County, Texas. (Cases)
3. Patients must sign an informed consent for the study. (Cases)
4. Women must speak and understand English or Spanish. (Cases)
5. Women who reside in Harris County, Texas. (Controls)
6. No history of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
7. Intact uterus. (Controls)
8. Patients must sign an informed consent for the study. (Controls)
9. Women must speak and understand English or Spanish. (Controls)
Exclusion Criteria:
1. Women who reside outside of Harris County, Texas. (Cases)
2. Patients unwilling or unable to provide informed consent. (Cases)
3. Metastatic cancer to the endometrium from a different primary. (Cases)
4. Women who do not speak and understand English or Spanish. (Cases)
5. Women who reside outside of Harris County, Texas. (Controls)
6. Previous hysterectomy. (Controls)
7. History of prior malignancy with the exception of non-melanoma skin cancer. (Controls)
8. Patients unwilling or unable to provide informed consent. (Controls)
9. Women who do not speak and understand English or Spanish. (Controls) | 25,392 |
Study Objectives
RATIONALE: Determination of genetic markers for colorectal cancer may improve the identification of patients who are at highest risk for relapse.
PURPOSE: This clinical trial is studying the importance of genetic markers for detecting relapse in patients with colorectal cancer.
Conditions: Colorectal Cancer
Intervention / Treatment:
GENETIC: DNA stability analysis, GENETIC: loss of heterozygosity analysis, GENETIC: microsatellite instability analysis
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Must have had a resectable adenocarcinoma of the colon or rectum and must have participated in one of the following NCCTG randomized clinical trials:
* 784852: No Treatment Control Versus Levamisole Versus Levamisole Plus Fluorouracil (5-FU)
* 794604: No Treatment Control Versus 5-FU by Portal Vein Infusion
* 794751: Postoperative Radiation Versus Postoperative Radiation Plus Sequential Chemotherapy with Methyl CCNU and 5-FU
* 844652: An Intergroup Study - An Evaluation of Levamisole Plus 5-FU as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
* 864751: Phase III Protocol for Surgical Adjuvant Therapy of Rectal Carcinoma: A Controller Evaluation of (A) Protracted-Infusion 5-FU as a Radiation Enhancer and (B) 5-FU Plus Methyl-CCNU Chemotherapy
* 874651: M/N - A Controller Evaluation of Recombinant Interferon-gamma (IFL GM) and 5-FU and Folinic Acid With or Without Levamisole as Adjuvant Treatment for Resectable Adenocarcinoma of the Colon
* 894651: A Controller Phase III Evaluation of 5-FU Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer
* Tissue blocks from the primary colorectal cancer must have been received by the NCCTG operations office | 15,170 |
Study Objectives
Postoperative cognitive dysfunction (POCD) is one of the common complications of cancer patients after operation with a 8.9%-46.1% incidence, which severely affecting patients' postoperative recovery, increasing the medical cost, affecting the social function of patients, reducing the quality of life and increasing the mortality.
Surgical trauma and perioperative pain can induce systematic inflammatory response and release systematic inflammatory mediators, which can enter the central nervous system (CNS) and lead to CNS inflammatory. In order to prevent the development of POCD among elder patients, the discovery of effective interventions reducing perioperative pain and inflammatory response is important.
Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive alternative to needle-based electro-acupuncture (EA). It combines the acupuncture and transcutaneous electrical nerve stimulation (TENS) by pasting the electrode piece on the acupoint instead of sticking the needles on the skin. TEAS can trigger the release of endogenous neurotransmitters, releasing endogenous analgesic substances, such as endorphins. TEAS also can reduce the intraoperative anesthetic consumption, postoperative pain score, postoperative nausea and vomiting (PONV), and improve the postoperative recovery of patients. Recently, TEAS was found to improve the cognitive function of geriatric patients with silent lacunar infarction. However, the current TEAS mainly focus on intraoperative. The effect of perioperative TEAS on POCD is not clear.
Here, the effect of TEAS on POCD in geriatric adults undergoing radical resection of gastrointestinal tumors under general anesthesia was investigated to determine whether TEAS can decrease perioperative pain or inflammatory response to prevent the occurrence of POCD and to find out the relationship among perioperative TEAS, inflammatory response, postoperative pain, and POCD preliminarily.
Conditions: Postoperative Cognitive Dysfunction
Intervention / Treatment:
DEVICE: Transcutaneous electrical acupoint stimulation
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
1. Patients aged 60 years or older;
2. Patients were diagnosed with gastrointestinal tumor and received radical; resection of gastrointestinal tumors under general anesthesia in Subei people's hospital of Jiangsu province;
3. The patients understood the research content and signed the informed consent form;
4. American Society of Anesthesiology (ASA) score I-III;
5. No frailty before operation;
6. D-dimer was normal before the operation
Exclusion Criteria:
1. Patients with cognitive dysfunction before the operation or patients with previous history of cognitive dysfunction, dementia and delirium;
2. Patients with a history of severe depression, schizophrenia and other mental and nervous system diseases or taking antipsychotic or antidepressant drugs in the past;
3. Patients with severe hearing or visual impairment due to eye or ear diseases without assistive tools;
4. Patients who are unable to communicate or have difficulty communicating;
5. According to the definition of "China chronic disease and its risk factors monitoring report (2010)" (male average daily pure alcohol intake ≥ 61g, female average daily pure alcohol intake ≥ 41g, alcohol volume (g) = alcohol consumption (ML) × alcohol content% × 0.8);
6. Patients who were hospitalized for three months or more before surgery or who had received surgical treatment within three months;
7. Patients who can't take care of themselves or are physically disabled and unable to carry out nerve function test;
8. Patients with severe heart, liver and renal failure;
9. Patients with hypoxemia (blood oxygen saturation \< 94%) more than 10 minutes during operation;
10. Patients admitted to ICU after operation;
11. Patients who quit or died due to noncooperation or sudden situation;
12. Patients who already participate in other clinical studies which may influence this study;
13. Patient who underwent emergency surgery;
14. Patient had a history of recent or conventional acupuncture treatment. | 40,438 |
Study Objectives
Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
Conditions: Acute Myeloid Leukemia, Minimal Residual Disease
Intervention / Treatment:
COMBINATION_PRODUCT: MRD-directed therapy
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision) | 39,172 |
Study Objectives
Interventions to promote physical activity among women breast cancer survivors (BCS) in low to middle-income countries are limited. We conducted a study to assess the acceptability and preliminary effectiveness of an 8-week, 3 times/week group dance intervention for BCS delivered in Bogotá, Colombia. The effect of the intervention on participants' physical activity levels, motivation to engage in physical activity, and quality of life were evaluated, and interviews were thematically analyzed to assess program acceptability.
Conditions: Physical Inactivity, Breast Cancer
Intervention / Treatment:
BEHAVIORAL: My Body, My Rhythm, My Voice
Location: Colombia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* BCS at least six months post treatment completion
* More than 18 years of age
* Living in Bogotá
* Willing to attend the program and the assessments
Exclusion Criteria:
* The presence of metastatic disease and other health conditions for which community physical activity was contraindicated | 19,535 |
Study Objectives
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.
Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.
Conditions: Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia, Metastatic Adenocarcinoma of Gastric Cardia
Intervention / Treatment:
DRUG: FOLFOX, DRUG: 5-FU, DRUG: Erlotinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
2. Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
3. Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
4. Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
5. ECOG performance status 0 or 1
6. Age \> 18 years old.
7. Life expectancy greater than 6 months.
8. Peripheral neuropathy: must be \< grade 1
9. Absolute neutrophil count \> 1,500/mm3
10. Hemoglobin \> 9.0 g/dl
11. Platelet count \> 100,000/mm3
12. Hepatic Function:
1. Total Bilirubin \< or = to 1.5 x ULN
2. AST and ALT must be \< or = to 3.0 x ULN (\< or = to 5.0 x ULN if there is liver metastasis).
13. Creatinine clearance of \> 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).
(Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
14. Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
15. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
16. Patients must have signed IRB approved informed consent
17. Patients must have the ability to comply with study and follow-up procedures.
Exclusion Criteria:
1. Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
2. Women who are breast-feeding or pregnant.
3. Presence of \> Grade 2 neuropathy
4. Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
5. Current or prior history of central nervous system or brain metastases
6. Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
7. Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
8. INR greater than 3.5 for patients on warfarin
9. Known HIV infection | 12,063 |
Study Objectives
Women who are overweight or do not exercise are at higher risk for breast cancer after menopause. This study will test a new electronic device that measures the body's movement and works alongside a website to help women increase their physical activity level. If effective, this system could be tested in larger studies aiming to reduce breast cancer risk by reducing or preventing obesity.
Conditions: Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Technology-Based Physical Activity Promotion, BEHAVIORAL: Pedometer Intervention
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Female
* Postmenopausal
* BMI \>= 25.0 kg/m2
* Physically inactive
* Internet user with regular access to high-speed internet
* Willing and able to complete study requirements
Exclusion Criteria:
* History of invasive breast cancer
* Medical contraindication to exercise
* Medical problem or other issue that would interfere with intervention
* Current participation in another physical activity study | 42,104 |
Study Objectives
To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer.
Conditions: Metastatic Breast Cancer, Recurrent Breast Cancer
Intervention / Treatment:
BIOLOGICAL: adenoviral vector encoding rat Her-2/neu
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. metastatic or locally recurrent breast cancer,
2. 18 years of age or older,
3. Her-2/neu positive (3+ by immunohistochemistry or FISH +),
4. One of the following
1. currently receiving hormonal therapy or are candidates for such or,
2. being considered for trastuzumab or,
3. their cancer has progressed on trastuzumab
Exclusion Criteria:
1. Pregnant or lactating women.
2. Prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured more than five years prior to study entry.
3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[Note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.\].
4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
5. Hemoglobin \< 80 g/L or granulocytes \< 1.5 x 109 /L or lymphocytes \< 1.0 x 109 /L or platelets \< 100 x 109 /L.
6. Baseline liver enzymes (AST or ALT) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol.
7. CD4 cells \< 0.5 x 109 /L
8. Patients with documented brain metastases.
9. Patients with any acute illness that would interfere with vaccination
10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
11. Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
12. Patients with a life expectancy of less than 6 months.
13. Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Jewish General Hospital.
14. Failure to give written informed consent.
15. Baseline left ventricular ejection fraction (LVEF) \< 55% by echocardiography or MUGA scan. | 18,282 |
Study Objectives
A randomized multi-center study comparing the effect of dasatinib and imatinib on malignant stem cells in newly diagnosed chronic phase chronic myeloid leukemia (CML) patients. The research hypothesis is that treatment with dasatinib 100 mg daily (QD) results in greater and more rapid depletion of the Philadelphia (Ph) -positive stem cell pool within 6 months of therapy than imatinib 400 mg QD in newly diagnosed CML patients. The study duration is 18 months and approximately 40 patients will be recruited to the study.
Conditions: Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: Imatinib, DRUG: Dasatinib
Location: Sweden, Norway, Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients are able to provide written informed consent
* Patients must have CML in CP which is defined by the presence of all of the following criteria:
* \< 15% blasts in peripheral blood (PB) and BM.
* \< 30% blasts plus promyelocytes in PB and BM.
* \< 20% basophils in the PB.
* ≥ 100 x 109/L platelets.
* No evidence of extramedullary leukemia apart from hepatosplenomegaly
* Ph+ or variants must be demonstrated by BM cytogenetics, FISH or PCR.
* Previously untreated CML in CP, with the exception of hydroxyurea or anagrelide
* Patients must be enrolled in this study within 90 days after the date of first being diagnosed with CML
* ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
* Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT≤ 2.5 times the institutional ULN.
* Adequate renal function defined as serum creatinine ≤ 2 times the institutional ULN.
* Men and women, ages 18 years and older.
* Adequate BM aspiration sample before the start of study treatment (i.e sample is sufficient for stem cell analysis)
* Potentially fertile women must use an adequate method of contraception to avoid pregnancy throughout the study.
* Potentially fertile women must have a negative serum or urine pregnancy test
Exclusion Criteria:
* Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
* Women who are pregnant or breastfeeding.
* Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
* Known pleural effusion at baseline.
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML, including:
* Prior chemotherapy for peripheral stem cell mobilization.
* Inadequate BM aspiration sample due to marrow fibrosis or other reasons
* Prior or concurrent malignancy
* Severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent
* Abuse of alcohol, prescribed or illicit drugs
* Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.
* Prohibited Treatments and/or Therapies
* Any prior treatment with interferon
* Any prior treatment with dasatinib
* Any prior treatment with imatinib
* Any other prior systemic treatments, with anti-CML activity \[except for anagrelide, or hydroxyurea (HU)\].
* Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes as described in Appendix 3. | 22,334 |
Study Objectives
The purpose of this study is to determine a dose for future development and to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy profiles of JNJ-42756493 in Japanese and other Asian patients with advanced or refractory solid tumors or lymphoma.
Conditions: Neoplasms, Lymphoma, Adenocarcinoma, Esophagogastric Junction
Intervention / Treatment:
DRUG: Part 1: JNJ-42756493, DRUG: Part 2: JNJ-42756493
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Part 1: Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative treatment is no longer effective
* Part 2: Histologically or cytologically confirmed gastric adenocarcinoma including gastroesophageal junctions that is metastatic, locally advanced or unresectable, and for which standard treatment is no longer effective or tolerable
* Eastern Cooperative Oncology Group performance status score 0 or 1
* Adequate bone marrow, liver, and renal function according to protocol-defined criteria within the 7 days prior to Day 1 of Cycle 1
* Laboratory values within protocol -defined parameters
* Agrees to protocol-defined use of effective contraception
* Negative urine pregnancy test (urine or serum beta human chorionic gonadotropin \[beta-HCG\]) at screening for women of child bearing potential
Exclusion Criteria:
* Has had chemotherapy, radiotherapy, immunotherapy, or treatment with an investigational anticancer agent within 3 weeks (nitrosoureas and mitomycin C within 6 weeks) before the first administration of study drug (localized radiation therapy for palliative purposes and ongoing luteinizing hormone-releasing hormone agonists and antagonists for patients with prostate cancer, bisphosphonates and denosumab are permitted
* History or current condition of uncontrolled cardiovascular disease as defined in the protocol
* Taking medications known to have a risk of causing QTc prolongation and Torsades de Pointes or known as strong CYP3A inhibitors or inducers
* Left ventricular ejection fraction less than (\<) 50 percent (%) as assessed by echocardiography (or multi-gated acquisition \[MUGA\]) performed at screening
* Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection, psychiatric illness, or a risk of gastrointestinal perforation
Woman who is pregnant, breast-feeding, or planning to become pregnant or is a man who plans to father a child, while the participant is enrolled in this study and is within 3 or 5 months, respectively, after the last dose of the study drug
* Not recovered from reversible, clinically significant toxicity of prior anticancer therapy
* Presence of any medical condition that requires intact wound healing capacity and is expected to endanger participant safety if wound healing capacity would be severely reduced during administration of the investigational agent
* Major surgery within 4 weeks before enrollment
* Known human immunodeficiency virus infection
* Known hepatitis B or C (except hepatocellular carcinoma)
* Active, symptomatic, or untreated brain metastasis | 29,292 |
Study Objectives
Numerous studies find that anesthetic methods may influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in the clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we will investigate the effects of anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
PROCEDURE: general anesthesia, PROCEDURE: local anesthesia
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* 18 to 65 years old
* ASA grade I-III
* Diagnosed with a single primary liver tumor of 3cm or smaller
* Is scheduled for elective radiofrequency ablation surgery
* With no macro-vascular invasion, no lymph node or extrahepatic metastases
* Child-Pugh Class A or B
Exclusion Criteria:
* a history of liver surgery previously (including radiofrequency ablation)
* severe systemic disease (heart, lung, kidney, or immune system)
* INR\>1.5 or platelet count \<45,000 cells/mm3
* a history of addiction to opioids;
* Disagree to participate the trial | 9,391 |
Study Objectives
This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg\~5.4 mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.
Conditions: HER2-positive Breast Cancer
Intervention / Treatment:
BIOLOGICAL: ALT-P7 (HM2-MMAE)
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: OTHER
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patient who voluntarily signed the agreement
2. Adult patients ≥ 19 years of age
3. Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1
4. Appropriate organism function proven by the following laboratory test results
* Absolute neutrophil count ≥ 1500 cells/mm³
* Platelets ≥ 100,000 cells/mm³
* Hemoglobin ≥ 9.0 g/dL
* Patients can receive red blood cell transfusions at this level.
* Creatinine ≤ 1.5 × Upper Limit of Normal(ULN)
* Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤ 2.5 × ULN
* Alkaline phosphatase ≤ 2.5 × ULN
* Patients with liver and/or bone metastases: AST and ALT ≤ 5 × ULN, Alkaline phosphatase ≤ 5 × ULN
* Albumin ≥ 3.0 g/dL, Total bilirubin ≤ 2.0 mg/dL
* International Normalized Ratio(INR) \< 1.5 × ULN(Except when you are on therapeutic anticoagulation therapy)
5. It should be negative in serum pregnancy test in the case of pre-menopausal women and women who were menopausal for less than 12 months
6. In the case of a fertile woman, it should be negative in pregnancy test, and all men and women should use effective contraceptive methods while enrolled in this study. You must also agree to continue the contraception during the trial and up to 6 months after the last dose of the test
7. Those who are expected to understand and observe the clinical trial plan according to the tester's judgment
8. Those who voluntarily agreed to participate in this clinical trial and signed the agreement
Exclusion Criteria:
* Criteria for disease
1. Previous history of intolerance to Trastuzumab including Grade 3-4 infusion reaction or hypersensitivity
2. Previous history of permanent discontinuation of Trastuzumab due to the toxicity
3. A person who has untreated or symptomatic brain metastasis, or brain metastasis requiring radiation, surgery or corticosteroid therapy to control the brain metastases within 4 weeks of the first administration
4. Current Grade ≥ 2 (according to National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) v4.03 of peripheral neuropathy
5. If the toxicity of the previous treatment is not recovered to baseline level or lower than Grade 1 except for hair loss and peripheral neuropathy
6. Hypercalcemia requiring bisphosphonate therapy (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN) However, it is allowed if bisphosphonate has been used for bone metastasis
7. A person who has received clinical trial material, chemotherapy, hormone therapy, radiotherapy, immunotherapy or biological therapy within 3 weeks of the first administration. However, it is required a minimum of 2 weeks after surgery if stereotactic radiosurgery is performed
8. Previous history of exposure to the cumulative dose of anthracycline (Doxorubicin \> 360 mg/m², Epirubicin \> 600 mg/m²)
* Criteria for cardio pulmonary function
1. Unstable ventricular arrhythmia requiring treatment
2. Previous history of symptomatic congestive heart failure (NYHA Class II-IV)
3. Previous history of myocardial infarction or unstable angina within 6 months
4. Cardiac troponin I ≥ 0.2 ng/mL
5. A person who has inadequate left ventricular ejection fraction(LVEF) within 3 weeks of the first administration, LVEF \<50% by echocardiography or Multiple-gated Acquisition(MUGA)
6. A person who has severe dyspnea or pneumonia requiring continuous oxygen therapy
* Common criteria
1. Pregnant or breastfeeding
2. A person who has undergone surgical operation or significant traumatic injury within 30 days before registration, or is expected to require surgical operation during the clinical trial
3. Previous history of malignant tumors other than breast cancer within 5 years prior to screening (patient who can participate: squamous cell and basal cell carcinoma of the skin, intraepithelial cancer of the cervix, thyroid papillary cancer, or if the tester considers that the risk of relapse is minimum(regard as full recovery) and the sponsor agrees with it)
4. A person who needs chronic corticosteroid therapy (≥ 10 mg/day prednisone or equivalent volume of other anti-inflammatory corticosteroids)
5. If the result of human immunodeficiency virus (HIV), active hepatitis B or hepatitis C is positive during screening
6. Patients with uncontrolled concomitant illnesses, including mental illness/social conditions, which may affect compliance with clinical trial procedures | 33,922 |
Study Objectives
Investigators propose to assess, retrospectively and prospectively the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (Avastin) as first line treatment of patients with advanced or metastatic Non Small Cell Lung Cancer.
All treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with advanced or metastatic Non Small Cell Lung Cancer.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
Location: Greece
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Signed informed consent prior to initiation of any trial-specific procedure or treatment
* Ability to comply with the protocol
* Histologically or cytologically (sample to be obtained by biopsy or bronchoscopy) confirmed non-squamous NSCLC (locally recurrent or metastatic) per investigator assessment
* At least 1 unidimensionally measurable lesion meeting RECIST criteria
* No prior first line treatment for metastatic colorectal cancer
* Age ≥18 years
* ECOG performance status ≤2
* Adequate haematological, renal and hepatic function
* Urine protein \<2+ (dipstick)
* International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN within 7 days prior to randomization, unless there is prophylactic use of anti-coagulation
* Patients with asymptomatic treated brain metastases are eligible for trial participation. Patients must complete treatment for brain metastases (radiotherapy with or without surgery, or stereotactic radiosurgery), including steroids, at least 28 days prior to randomization. Treatment with anticonvulsants at the time of randomization (i.e. ≥ 28 days) is allowed as long as the anti-convulsant is at a stable dose)
* Female patients must not be pregnant or breast-feeding. Female patients of childbearing potential (defined as \>2 years after last menstruation or surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, are implants, injectables, combined oral contraceptives, intra-uterine device \[IUD; only hormonspirals\], sexual abstinence or vasectomized partner) during the trial and for a period of at least 6 months following the last administration of trial drug(s).Female patients with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the trial
* Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1% per year, include a female partner using implants, injectables, combined oral contraceptives, IUDs \[only hormonspirals\], sexual abstinence or prior vasectomy) during the trial and for a period of at least 6 months following the last administration of trial drug(s)
Exclusion Criteria:
* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* History of hemoptysis ≥ grade 2 (defined as bright red blood of at least 2.5 mL) within 3 months prior to randomization
* Surgery (including open biopsy), significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during trial treatment
* Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
* Evidence of tumor invading or abutting a major blood vessel (e.g., pulmonary artery or superior vena cava) on imaging
* Radiotherapy to any site for any reason within 28 days prior to randomization. Palliative radiotherapy to bone lesions within 14 days prior to randomization is allowed
* Current or recent (within 10 days prior to first dose of bevacizumab) use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose (i.e. therapeutic dose) oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed.
* History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding
* Active gastrointestinal bleeding
* Inadequately controlled hypertension (blood pressure: systolic \> 150 mmHg and/or diastolic \> 100 mmHg) within 28 days prior to randomization or history of hypertensive crisis or hypertensive encephalopathy
* Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident \[CVA\] or myocardial infarction within 6 months prior to randomization, unstable angina, congestive heart failure \[CHF\] New York Heart Association \[NYHA\] Class ≥ II, or serious cardiac arrhythmia), that is uncontrolled by medication or may interfere with administration of trial treatment
* Non-healing wound, active peptic ulcer or untreated bone fracture
* History of abdominal fistula, gastrointestinal perforation or intra abdominal abscess within 6 months prior to randomization.
* Treatment with any other investigational agent within 28 days prior to randomization. Patients in the follow-up phase of 1st-line trials who fulfill all eligibility criteria may be enrolled in this trial if the 1st-line protocol allows bevacizumab-based treatment in the follow-up phase
* Known hypersensitivity to bevacizumab or any of its excipients, or any of the SOC agents foreseen
* Malignancy other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, and ductal carcinoma in situ (DCIS) treated surgically with curative intent
* Evidence of any other disease, neurologic or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational or SOC drug used in this study or puts the patient at higher risk for treatment-related complications | 7,162 |
Study Objectives
This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.
Conditions: Metastatic Castration-Resistant Prostate Cancer
Intervention / Treatment:
DRUG: ZEN003694
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Males age ≥ 18 years
2. Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening
3. Serum testosterone \< 50 ng/dL determined within 4 weeks of first administration of study drug
4. Prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, TAK-700 and/or galeterone) by Prostate Cancer Working Group 2 (PCWG2) criteria. Prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate laboratory parameters \[absolute neutrophil (ANC), platelets, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, creatinine and coagulation parameters\] at screening
Exclusion Criteria:
1. Any history of brain metastases or prior seizure or conditions predisposing to seizure activity
2. Have previously received an investigational BET inhibitor (including previous participation in this study or Study ZEN003694-002)
3. Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
4. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
5. Radiation therapy within 2 weeks of first administration of study drug
6. Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry)
7. Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug. | 22,624 |
Study Objectives
The standard treatment for nasopharyngeal cancer involves either radiation alone or radiation plus chemotherapy. Before the start of treatment,patients require an imaging scan to assess the extent of disease. The most commonly used test is a magnetic resonance imaging (MRI) scan.
The goal of the study is to examine the value of a new imaging technology that has recently become available at the University Health Network Hospitals called Positron Emission Tomography scanning (PET). PET scanning involves the injecting a small amount of a drug through a vein in the arm called 18-fluorodeoxyglucose (18FDG). This drug is special in that it is radioactive and will be detected by the PET machine. Cancer cells are believed to be more active than normal cells and have a high rate of metabolism. Therefore, cancer cells are thought to take up glucose (a kind of sugar) faster than normal cells in the body. Because 18FDG is a modified type of glucose, it is also taken up by cancer cells. Special imaging cameras will be able to visualize the areas of uptake and reveal sites of cancer involvement. The main goal of this study is to evaluate whteher the scan is able to detect the presence of nasopharyngeal carcinoma (NPC) both before and after treatment and to specifically compare it to findings on magnetic resonance imaging scans (MRI).
In addition to doing the PET scans, we are asking patients to have blood samples drawn throughout their treatment and follow-up, for a research test called Epstein Barr virus (EBV) DNA levels. The Epstein Barr virus is thought to have a role in the development of nasopharyngeal cancer, and many patients with nasopharyngeal carcinoma are found to have high levels of EBV DNA levels in their blood. The second goal of this study is to evaluate whether changes in EBV DNA levels are associated with the treatment and the disease course in nasopharyngeal cancer, and whether they help to predict any changes in the cancer. This part of the study involves the sampling of a small amount of venous blood at a time prior to the beginning of therapy and at regular intervals following treatment.
Conditions: Nasopharyngeal Carcinoma
Intervention / Treatment:
Location: Canada
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
- 1. Patients with histologically diagnosed nasopharyngeal carcinoma presenting to the University Health Network for which a course of curative radiation therapy +/- chemotherapy is planned.
2. Patient is able to provide informed consent and is willing to adhere to the study protocol.
Exclusion Criteria:
- 1. Patients with metastatic disease. 2. Lactating or pregnant females. 3. Medical or psychological conditions such as claustrophobia, etc., that in the opinion of the referring MD or study investigator, would make the patient unable to tolerate the study procedures.
4. Presence of a second malignancy or a history of another malignancy active within the last 5 years, with the exception of non-head and neck, non-melanomatous cutaneous malignancy. | 37,907 |
Study Objectives
The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be studied. Researchers will also use samples of the original tumor or metastatic tissue (for example, lymph nodes or liver or lung) that are collected during screening to study if response to the study drug is related to the genes in the tissue.
Conditions: Melanoma
Intervention / Treatment:
DRUG: HDIL-2, BIOLOGICAL: recMAGE-A3 + AS15
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. STEP 1 Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
2. Male or female patient with histologically proven, measurable unresectable or metastatic cutaneous melanoma
3. Patient is \>/= 18 years of age.
4. Formalin-fixed paraffin-embedded (FFPE) tumor tissue must be available for MAGE-A3 expression screening test from cutaneous, subcutaneous, lymph node lesion, lung or liver lesion. Archival FFPE tumor tissue can be provided for the MAGE-A3 screening test, as long as the FFPE tumor tissue was obtained from a biopsy or resection and no systemic chemotherapy, immunotherapy or targeted therapy has been received by the patient between the tumor collection and the MAGE-A3 screening test. Fresh tumor tissue in RNAlater must be also available for gene signature testing. Patients must have at least one biopsiable cutaneous, subcutaneous, lymph node lesion, The tumor sample should be preferably from the same lesion as the FFPE tumor tissue. Cutaneous lesions must measure \>/= 4mm and lymph nodes, subcutaneous, lung or liver lesions must measure \>/= 1cm.
5. STEP 2 ANA (antinuclear antibody) titer \< 1:80
6. STEP 2 The patient's tumor shows expression of MAGE-A3 gene.
7. ECOG performance status of 0 or 1.
8. WBC \>/= 3000/mm\^3 and Hemoglobin \>/= 9 g/dl
9. Platelet count \>/= 100,000/mm\^3.
10. Normal AST and ALT except for patients with liver metastases, in which serum ALT and AST \</= 2.5 X upper limit of normal (ULN) will be permitted.
11. Creatinine \</= 1.5 mg/dL
12. Normal total bilirubin except for patients with liver metastases, in which total bilirubin \</= 1.5 X ULN will be permitted (patients with Gilbert's syndrome must have a total bilirubin less that 3.0 mg/dL).
13. LDH \</= 2 X ULN
14. Stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram or other stress test that will rule out cardiac ischemia) with estimated ejection fraction \>50% within 6 months of signing consent form
15. Pulmonary function tests showing FEV1 \> 65% or FVC \> 65% of predicted within 6 months of signing consent form
16. Women of childbearing potential (WOCBP) must be using an adequate method of contraception prior to treatment, throughout the study, and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. In general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as: Amenorrhea for 12 consecutive months without another cause, or For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level 35 mIU/mL.
17. (Continued #16) Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days before the start of treatment.
18. Men must also agree to use an adequate method of contraception.
Exclusion Criteria:
1. The patient has at any time received systemic chemotherapy, immunotherapy or targeted therapy (except for isolated limb perfusion, interferon, or radiation in the adjuvant setting, as long as this was performed at least 4 weeks before first study treatment administration).
2. Brain metastasis or history of brain metastasis.
3. Any types of melanoma other than cutaneous, i.e. ocular or mucosal .
4. The patient received any cancer immunotherapeutic containing a MAGE-A3 antigen.
5. Patients with a history of second malignancies are eligible provided that they have been free of recurrence from secondary malignancy for at least 3 years, does not include squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ.
6. The patient has a history of an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, rheumatoid arthritis, and inflammatory bowel disease or an antinuclear antibody (ANA) titer \> 1:80.
7. The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational compound.
8. The patient has a family history of congenital or hereditary immunodeficiency.
9. Known to be positive for viral hepatitis B or C (HBsAg or Anti HCV) or HIV (HIV antibodies) Patients should have a negative test within 6 months of starting treatment.
10. Systemic steroid therapy, steroid-containing compounds or any other immunosuppressive agents or to be used for more than 7 consecutive days (at a dose of prednisone or equivalent of \>/= 0.125 mg/kg/day).
11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures. Each patient will be evaluated by the principal investigator or his designee.
12. The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. Each patient will be evaluated by the principal investigator or his designee.
13. Initiation of another anti-cancer therapy.
14. For female patients: the patient is pregnant or lactating.
15. WOCBP who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy. | 14,283 |
Study Objectives
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow tissue samples obtained during the protocol screening process to be used for future and ongoing research in the NCI Surgery Branch
Eligibility:
Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol
Design
Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol
Conditions: Gastrointestinal Cancer, Liver Cancer, Pancreatic Cancer, Melanoma
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * INCLUSION CRITERIA:
* Patients must be greater than or equal to 18 years of age.
* Patients who have a premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up.
* Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
* Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.
* Patients who agree to undergo leukapheresis must meet the following criteria:
* Seronegative for HIV
* Seronegative for hepatitis B surface antigen and seronegative for
antibody to hepatitis C.
- CBC within normal limits | 1,549 |
Study Objectives
This study aims to evaluate the efficacy brentuximab vedotin as consolidation treatment in patients with stage I/II Hodgkin's lymphoma and 18-fluorodeoxyglucose (FDG) -PET positivity after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine).
Conditions: Hodgkin Lymphoma
Intervention / Treatment:
DRUG: brentuximab vedotin, DRUG: Cyclophosphamide, DRUG: Adriamycin, DRUG: Oncovin, DRUG: Bleomycin, DRUG: Etoposide, DRUG: Procarbazine, DRUG: Prednisone, DRUG: G-CSF, RADIATION: 30 Grays
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients must have histologically confirmed cluster of differentiation antigen 30+ (CD30+) classical Hodgkin lymphoma
2. Patients must have provided voluntary written informed consent
3. Supradiaphragmatic Ann Arbor clinical stage I or II
4. Mandatory PET scan performed at diagnosis
5. Patients treated with first-line ABVD and PET scan positive after 2 cycles (Deauville score 4 \& 5)
6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Life expectancy \> 6 months
8. Patients must be 18-65 years of age
9. Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution
10. Female patients who:
* Are postmenopausal for at least 1 year before the screening visit OR are surgically sterile OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception at the same time
11. Male patients, even if surgically sterilized, who agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
12. Clinical laboratory values as specified below before the first dose of study drug:
* Absolute neutrophil count ≥ 1,500/µL
* Platelet count ≥ 75,000/ µL
* Total bilirubin must be \< 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)must be \< 3 x the upper limit of the normal range
* Serum creatinine must be \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute
* Hemoglobin must be ≥ 8g/dL
13. Patient affiliated to social security system
Exclusion Criteria:
1. Patients with dementia or altered mental status that would preclude compliance with drug delivery
2. Women who are pregnant or breastfeeding
3. Patients with symptomatic pulmonary disease
4. Patients with known history of any of the following cardiovascular conditions:
* Myocardial infarction within 2 years of inclusion
* New York Heart Association (NYHA) Class III or IV heart failure
* Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \<50%
5. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection
6. Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection defined by either detection of Hepatitis B surface (HBs) Antigen or presence of Hepatitis B core (HBc) antibody without detectable anti HBs antibody
7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose
8. Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity
9. Patients who have been treated previously with any anti-CD30 antibody
10. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
11. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
13. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment | 44,578 |
Study Objectives
To ascertain the possibilities to isolate the breast cancer olfactive signature
Conditions: Breast Cancer, Surgery
Intervention / Treatment:
DIAGNOSTIC_TEST: Sorbstar®, DIAGNOSTIC_TEST: Dog Detection
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: TRIPLE | Inclusion Criteria:
1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
2. Of-Age female patient (over 18 years old)
3. Life expectancy \> to 1 year at the inclusion
4. ECOG performance status: 0 or 1 or 2
5. Patient benefiting from the social security
6. Signature informed consent of the study
Exclusion Criteria:
1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
2. Wound presence on breasts
3. Male subjects
4. Pregnant or lactating women
5. Specified metastatic breast cancer
6. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
7. Persons under guardianship or deprived of liberty
8. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons. | 35,671 |
Study Objectives
The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Bortezomib
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Participants previously diagnosed with multiple myeloma based on standard criteria
* Participant has received at least 2 previous lines of therapy for multiple myeloma and, in the Investigator's opinion, currently requires therapy because of relapsed (the return of a medical problem) or progressive disease
* Female participants either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control from Screening through the Final Visit
* If male, the participant agrees to use an acceptable barrier method for contraception from Screening through the Final Visit
* Participant has a Karnofsky performance status classifies participants as to their functional impairment and is used to compare effectiveness of different therapies and to assess the prognosis \[outlook, probable outcomes\] in individual participants) greater than 60
Exclusion Criteria:
* If the participant received bortezomib in a previous trial, the Participants' best response to bortezomib must be progressive disease
* If the participant received bortezomib in a previous trial, the participant must have experienced 1 or more serious adverse events
* Participants who have received nitrosoureas within 6 weeks or any other chemotherapy (treatment of disease, usually cancer, by chemical agents) within 3 weeks before enrollment
* Participants who have received corticosteroids (greater than 10 milligram per day prednisone or equivalent) within 3 weeks before enrollment
* Human Immunodeficiency Virus (HIV - a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person)-positive or hepatitis-B surface antigen-positive participants or participants with known active hepatitis-C infection | 30,928 |
Study Objectives
Vitamin D(Vit D) is a pro-differentiation agent that enhances the accumulation of protoporphyrin IX (PpIX) after MAL(methyl-aminolevulinate) incubation in actinic keratosis and may have significant benefit for the treatment of actinic keratosis by ablative fractional laser-primed photodynamic therapy (AFL-PDT).
Conditions: Actinic Dermatosis
Intervention / Treatment:
DRUG: Topical Vitamin D (Calcipotriol) application, DRUG: Placebo cream application, DRUG: lidocaine/prilocaine (5%) application, DEVICE: 2940-nm Er:YAG AFL pretreatment, DRUG: MAL application, OTHER: Measurements of the fluorescence intensity, DEVICE: irradiation with red light-emitting diode lamp
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: TRIPLE | Inclusion Criteria:
* Korean patients aged ≥ 18 years who had biopsy-confirmed Actinic keratosis lesions
Exclusion Criteria:
* calcium metabolic disorder patients
* photosensitivity disorder patients
* lactating or pregnant women
* patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment | 4,068 |
Study Objectives
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.
The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.
Conditions: Length of Stay, Postoperative Complications, CRP
Intervention / Treatment:
PROCEDURE: pre-operative assessment, counseling and education, PROCEDURE: Preoperative nutritional drink up to 4 h prior to surgery, PROCEDURE: bowel preparation, PROCEDURE: preoperative treatment with carbohydrates, PROCEDURE: fast solid, PROCEDURE: avoiding hypothermia, PROCEDURE: Postoperative glycaemic control, PROCEDURE: postoperative nausea and vomiting (PONV) control;, PROCEDURE: early postoperative diet, PROCEDURE: pre-operative fasting at least 8h, PROCEDURE: bowel preparation for traditional surgery, PROCEDURE: began to take solid diet after anal exhaust
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
2. Aged 18 years or older
3. Signed informed consent provided
Exclusion Criteria:
1. Patients with a documented infection at the time of operation
2. Aged 71 years or older
3. Patients with ileus at the time of operation
4. Patients with hypocoagulability
5. Patients with psychosis, Alcohol dependence or drug abuse history
6. Patients with primary nephrotic or hepatic disease
7. Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure\>90mmHg | 12,710 |
Study Objectives
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Zoledronic acid, DRUG: Letrozole
Location: Argentina, Korea, Republic of, Saudi Arabia, Netherlands, Belgium, South Africa, Spain, France, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Stage I-IIIa breast cancer
* Postmenopausal
* Recent surgery for breast cancer
Exclusion Criteria:
* Metastatic disease
* Invasive bilateral disease
* Clinical or radiological evidence of existing fracture in spine or hip
Other protocol-defined inclusion / exclusion criteria may apply. | 14,944 |
Study Objectives
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
Conditions: Pain, Cancer
Intervention / Treatment:
DRUG: OraVescent fentanyl citrate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* 18-80 years of age
* Average of 1-4 breakthrough pain episodes per day
* Opioid tolerant
* Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
Exclusion Criteria:
* Primary breakthrough pain is not related to cancer in any way
* Opioid or fentanyl intolerance
* Chronic obstructive pulmonary disease (COPD) or heart disease
* Sleep apnea or active brain metastases with increased cranial pressure | 29,606 |
Study Objectives
RATIONALE: The Chinese herb Huang Lian contains ingredients that may slow the growth of cancer cells and may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of Huang Lian in treating patients who have advanced solid tumors.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: Chinese Herb Huanglian (Coptis chinesis)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists
* Measurable or evaluable disease
* No CNS primary tumor or metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,500/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No history of cardiac arrhythmias (including atrial fibrillation)
* No congestive heart failure
* No angina or myocardial infarction within the past 6 months
* QTc interval no greater than 0.48 sec
Other:
* Potassium at least 3.5 mEq/L
* Magnesium at least 1.4 mEq/L
* No mental incapacity that would preclude informed consent
* No serious or uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* At least 2 weeks since prior herbal therapy for cancer and recovered
* No concurrent class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide, sotalol, amiodarone, ibutilide, almokalant, or dofetilide)
* No concurrent tricyclic antidepressants (e.g., amitriptyline, doxepin, desipramine, imipramine, or clomipramine)
* No concurrent antiseizure medication (including dilantin and phenobarbital) for any underlying seizure disorder | 44,984 |
Study Objectives
The primary objective of this study is to obtain infrared (IR) images and video and three-dimensional (3-D) scans of patients referred for biopsy based on the results of their diagnostic breast exam(s).
This research study is investigating infrared imaging (also referred to as infrared thermography, or digital infrared thermal imaging (DITI)) of breast cancer. The infrared images collected in this study will be used to construct a computational biothermal engineering model of the cancerous breast.
Patients will undergo standard breast cancer screening procedures as part of routine care at Parkland Comprehensive Breast Center. For any patients who are referred for biopsy based on the results of their breast cancer screening procedures, this research study will take infrared images of the patient. Patients will undergo infrared imaging prior to biopsy but will not delay biopsy or treatment; infrared images \& video may be recorded at biopsy visit. The biopsy will confirm/diagnose whether the patient has a benign or malignant condition.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: IR Imaging, PROCEDURE: 3D Scanning
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Females with a suspicious breast mass (BI-RADS 4C or 5).
* Referred for a breast biopsy.
* Capable of providing informed consent.
Exclusion Criteria:
* Currently undergoing treatment for breast cancer.
* Incapable of providing informed consent. | 12,630 |
Study Objectives
HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.
Conditions: HPV, Human Papilloma Virus
Intervention / Treatment:
DIAGNOSTIC_TEST: polymerase chain reaction
Location: Germany
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* pts. who suffer from vulvar cancer and their preinvasive lesions
* positive informed consent
* complete set of data
* Treatment in luebeck university
Exclusion Criteria:
* opposite of above | 12,335 |
Study Objectives
The purpose of this project is to assess the efficacy of loratadine in decreasing the incidence and severity of bone pain following G-CSF administration in patients with hematologic malignancies, patients undergoing mobilization of hematopoietic progenitor cells, and patients who have undergone an autologous hematopoietic cell transplant. This is a different patient population than those being assessed in current clinical trials.
Conditions: Leukemia, Lymphoma
Intervention / Treatment:
DRUG: Loratadine
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Receiving a G-CSF after the institution practice change
* Receiving a G-CSF for one of the following indications:
* Prevention/treatment of neutropenia along with treatment for leukemia or lymphoma
* Mobilization of hematopoietic progenitor cells
* Neutropenia prevention following autologous hematopoietic cell transplant
* Took loratadine per protocol with G-CSF administration
* Completed a survey
Exclusion Criteria:
* Taking daily antihistamines for allergies, asthma, or other indications, not including bone pain
* Taking daily NSAIDs, with the exception of aspirin, for chronic conditions
* Treatment for solid tumor cancers
* Receiving bone modifying agents for bone pain associated with metastatic disease or other chronic conditions | 17,678 |
Study Objectives
Recent investigations have demonstrated that DNMT gene polymorphisms can contribute to the inter-individual variants in DNMT expression. Accordingly, we hypothesized that the DNMT and HDAC genes SNPs could predict the outcomes of decitabine therapy for myelodysplastic syndrome. Prospective collection of DNA from peripheral blood will be performed in the patients with MDS before commencement of decitabine therapy. We will evaluate the efficacy decitabine therapy according to the DNMT or HDAC gene SNPs in terms of following parameters: 1) hematolotic response (HR) or improvement (HI), or requirement of decitabine dose to achieve HR or HI, 2) complete (CR) or partial response (PR), or requirement of decitabine dose to achieve CR or PR, and 3) time to relapse or progression of MDS.
The objective of this study is 1) to determine genotypes from DNA samples from MDS patients receiving Decitabine therapy, 2) to determine the association of clinical outcomes (HR, HI, CR, PR or time to progression to leukemia) following decitabine therapy with DNMT or HDAC genotypes, and 3) to analyze the impact of cytogenetic risk on the response or leukemic evolution following decitabine therapy for MDS.
Conditions: Myelodysplastic Syndrome
Intervention / Treatment:
Location: Korea, Republic of
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | 1. Inclusion Criteria:
1. Decitabine treatment group
* Male and female aged 18 years or older.
* The patients diagnosed with (primary or secondary) MDS
* Patients with an IPSS score of ≥ Int-1
* Patients treated with Decitabine at least 1 cycles.
* Signed and dated informed consent before the start of genetic study using genomic DNA derived from blood sample.
2. Historical control group
* Male and female aged 18 years or older.
* The patients diagnosed with (primary or secondary) MDS
2. Exclusion Criteria:
* Patients diagnosed with acute myelogenous leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases.
* Diagnosis of chronic myelomonocytic leukemia (CMML) or MDS/MPD excluded. | 12,325 |
Study Objectives
This pilot study involves very frequent monitoring of breast cancer patient blood levels of hs-cTnT Troponin and n-t-BNP (Brain Natriuretic Peptide) before and after initiation of chemotherapy with either adriamycin or trastuzumab in order to define the kinetics of both biomarkers during the first two cycles of chemotherapy. Cardiac troponins and BNP are frequently elevated after experimental chemotherapy in animal models. Their behavior in humans has been inconsistent, with occasional elevations seen, usually within 30 days of therapy. Assays for troponin with sensitivity into the pg/ml range have now been introduced. A majority of patients greater than age 50 have elevations above the detection limit, compared to only 1-3% with conventional troponin assays, and over 90% of diabetics have elevations above the detection limit. Moreover, augmented release of high sensitivity troponin is detected after exercise or rapid atrial pacing of durations of 10-15 minutes in patients with and without coronary artery disease. This improved sensitivity suggests the potential for detection and monitoring of cardiac damage after cancer chemotherapy. We hypothesized that this new generation of troponin assay would be associated with kinetic behavior suggesting ongoing cardiac damage with anthracycline therapy, and possibly also with trastuzumab.
Conditions: Breast Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Female adult patients aged 18+
* Group 1: beginning clinically- indicated chemotherapy for breast cancer with a dose-dense (every 2 weeks) regimen including adriamycin (n=10).
* Group 2: patients who receive trastuzumab in and adjuvant, (neo) adjuvant, or metastatic setting in a regimen that does not include simultaneous adriamycin.
Exclusion Criteria:
* Inability to return to the clinic for regular phlebotomy
* Baseline hemoglobin \< 10 gm/dl
* Creatinine clearance \< 60 ml/minute (this effects troponin clearance)
* Recent (\< 3 months) cardiac surgery, myocardial infarction, unstable angina, or hospitalization for congestive heart failure | 34,111 |
Study Objectives
This study will evaluate the mass balance of talazoparib after a single dose of talazoparib.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: Talazoparib
Location: Hungary
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. At least 18 years of age and willing and able to provide informed consent.
2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.
3. Eastern Co-Operative Oncology Group (ECOG) performance status ≤ 2 at screening and Day -1.
4. Expected life expectancy of ≥ 3 months.
5. Able to swallow the study drug and comply with study requirements.
6. Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or of childbearing potential using a highly effective form of contraception, and female subjects should not donate eggs from the time point of IMP administration until at least 45 days thereafter.
7. Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential from 21 days before the first dose of study drug through 105 days after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.
8. Female patients must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.
9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion Criteria:
1. Treatment within 14 weeks or five half-live prior to dosing with any type of systemic anticancer therapy or any investigational agent, whichever is longer.
2. Major surgery within 8 weeks before screening.
3. Serious accompanying disorder or impaired organ function.
4. Symptomatic or impending spinal cord compression or cauda equina syndrome.
5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture caused by a pre-existent pathological bone lesion.
6. Known myelodysplastic syndrome.
7. Patients with the following serologies should be excluded: HBsAg+ or anti-HBc+; HCV+; HIV+.
8. Serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
9. Gastrointestinal disorder affecting absorption.
10. Known hypersensitivity to any of the talazoparib solution components.
11. Use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BRCP within 7 days or 5 half-lives, whichever is longer, before Day 1.
12. Any condition or reason that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Sponsor (e.g. non-compliance, excessive alcohol consumption, intake of drugs of abuse unless these drugs are medically indicated \[e.g. opiates for pain relief\]). | 9,994 |
Study Objectives
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
Conditions: Neuroblastoma
Intervention / Treatment:
BIOLOGICAL: monoclonal antibody 3F8, BIOLOGICAL: sargramostim
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Neuroblastoma diagnosed by INSS criteria, i.e., either:
* Histologic proof of disease OR
* Tumor clumps in bone marrow plus elevated catecholamine levels
* Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
* N-myc amplification in tumor cells
* Diploid chromosomal content in tumor cells
* Distant skeletal metastases
* Unresectable primary tumor crossing the midline
* Bone marrow with greater than 10% tumor cells
* Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
* No rapidly progressive disease
* Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols
PATIENT CHARACTERISTICS:
Age:
* 2 to 21
Performance status:
* Not specified
Life expectancy:
* Greater than 8 weeks
Hematologic:
* Not specified
Hepatic:
* No grade 3/4 toxicity
* LDH no greater than 1.5 times upper limit of normal
Renal:
* Creatinine clearance at least 60 mL/min
* No grade 3/4 toxicity
Cardiovascular:
* No grade 3/4 toxicity
Pulmonary:
* No grade 3/4 toxicity
Other:
* No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
* No active life threatening infections
* No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
* No allergy to mouse proteins
* No pain requiring opiates
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified | 3,803 |
Study Objectives
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 48-hour infusion every 14 days and as a 2-hour infusion for 2 consecutive days every 14 days in patients with advanced solid malignancies.
Conditions: Tumors
Intervention / Treatment:
DRUG: AZD1152 part A, DRUG: AZD1152 part B
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological or cytological confirmation of a solid, malignant tumour
* At least one measurable or non-measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Exclusion Criteria:
* Participation in an investigational drug study within the 21 days prior to therapy or those who have not recovered from the effects of an investigational study drug
* Recent major surgery within 4 weeks prior to entry into the study | 3,566 |
Study Objectives
Skin cancer is the most common cancer and can be deadly, debilitating, damaging, and disfiguring, yet is highly preventable. In 2014, the US Surgeon General made a call to action about the "major public health problem" of skin cancer, noting potential contributions of behavioral science and education, and a need for investments in such efforts. Almost five million Americans are treated for skin cancer annually, and incidence is rising. Risk factors for melanoma and non-melanoma skin cancers include personal or family history of skin cancer, certain physical characteristics (e.g., fair skin, numerous moles), as well as excessive ultraviolet (UV) radiation exposure. Our work shows that skin cancer risk behaviors, including sunburns, indoor tanning, and lack of protection peak at age 25. Thus, young adulthood is an important window for skin cancer risk reduction interventions. However, young adults tend to be resistant to public health recommendations because, as a group, they perceive themselves as having more immediate priorities than disease prevention, that the consequences of their current health behaviors are in the distant future, and they also tend to be experimenters and risk-takers highly influenced by peers.
The principal investigator developed a web-based intervention (UV4.me) that was found to significantly decrease UV exposure and increase skin protection behaviors among young adults in a randomized controlled trial of nearly 1000 participants.
The objective of this project is to investigate the reach, effectiveness, implementation, maintenance, and cost of an enhanced version of that web intervention (UV4.me2) in a large national randomized controlled trial. The ultimate goal is to improve the skin cancer protection behaviors (and potentially decrease skin cancer incidence) among a national sample of young adults at moderate to high risk of developing skin cancer.
Primary Aim 1. To enhance and determine intervention reach (i.e., enrollment, representativeness).
Primary Aim 2. To determine the effectiveness of the enhanced intervention.
Secondary Aim 1. To determine maintenance of the UV4.m4 and UV4.me2 interventions through evaluation at 6 and 12-month follow-up.
Secondary Aim 2. To determine intervention implementation by young adults.
Secondary Aim 3. To determine the costs of the UV4.me and UV4.me2 interventions.
Conditions: Melanoma and Other Malignant Neoplasms of Skin
Intervention / Treatment:
BEHAVIORAL: UV4.me2, BEHAVIORAL: UV4.me, BEHAVIORAL: E-Pamphlet
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Moderate to high risk for skin cancer
Exclusion Criteria:
* Not able to speak English
* Past history of skin cancer | 5,174 |
Study Objectives
This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial. One-hundred-and-five post NSM patients from Oct 2019 to Nov 2021 have been recruited prospectively and evaluated for NAC sensory. A total of 97 patients (IMF 65 and peri-areolar/radial 32) were included in the analyses for comparison during follow up from 24 to 48 months after surgery. It was hypothesized that patients with IMF would have better outcomes for NAC senroy.
Conditions: Breast Cancer, Nipple Sparing Mastectomy
Intervention / Treatment:
BIOLOGICAL: Nipple sparing mastecomy with different incision placements
Location: Korea, Republic of
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Females who are older than 18
2. Patients who underwent nipple sparing mastectomy in Gangnam Severance Hospital
Exclusion Criteria:
1. Loss or excision of NAC due to post-surgical necrosis
2. Diagnosis of other conditions that may interfere with cutaneous sensation | 34,726 |
Study Objectives
Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Advanced treatments make survival rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. Physical therapy may have benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and oral structures coordination. Return to work in the number of cancer survivors is a realistic outcome. Rehabilitation effects on functional restorations and quality of life for head and neck survivors are needed for further studied.
The purpose of this project is to explore the rehabilitation effects following head and neck reconstructive survivors. The investigators measure temporomandibular joint function, shoulder function, pain monthly. Physical functions, self-reported quality of life, and the status of return to work are measured 3 and 6 months after surgery. This prospective study could help to predict the rehabilitation outcomes and benefits.
Conditions: Head and Neck Cancer, Oral Cancer
Intervention / Treatment:
OTHER: Physiotherapy
Location: Taiwan
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Clinical diagnosis of oral cancer
* Post-reconstructive surgery
* Age between 20 to 65 years old
* Must be able to follow instructions
Exclusion Criteria:
* Central nervous disease
* Metastasis | 33,026 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining methotrexate with vinblastine may be effective treatment for neurofibromatosis type 1 associated with progressive plexiform neurofibromas.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas.
Conditions: Neurofibromatosis Type 1, Precancerous Condition
Intervention / Treatment:
DRUG: Methotrexate, DRUG: Vinblastine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Progressive, debilitating, severely disfiguring or life-threatening plexiform neurofibroma (PN) which is not surgically resectable and for which there is no other standard medical management. Histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings. However, if any clinical observation or scan suggests possible malignant transformation, the tumor must be biopsied prior to therapy. In addition to PN, all study subjects must have at least one other diagnostic criteria for Neurofibromatosis type 1 (NF1) listed below:
* 6 or more café-au-lait spots \> 0.5 cm in prepubertal subjects or \> 1.5 cm in postpubertal subjects
* freckling in the axilla or groin
* optic glioma
* 2 or more lisch nodules
* a distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)
* a first degree relative with NF1
2. Adequate bone marrow, renal, hepatic function:
* Absolute Neutrophil Count (ANC)\> 1000 and platelet count \>100,000 prior to initiation of therapy
* must have normal renal function: Blood Urea Nitrogen (BUN)/Creatinine \<1.5x normal for age), alkaline phosphatase (ALP), albumin, total protein and bilirubin
* must have normal liver function: Bilirubin, alanine transaminase (ALT), aspartate aminotransferase (AST) \< 1.5x normal for age
3. Patients must have measurable PN by direct physical examination (documented by clinical measurement of tumor and serial photography) or by imaging studies. Most patients will have tumors that can be measured by magnetic resonance imaging (MRI), however, some patients may have cosmetically disfiguring PN which would be best measured clinically and with serial photography throughout treatment and follow-up. A measurable lesion is one whose size can be quantified in at least 2 dimensions. There must be evidence of recurrent or progressive disease as documented by an increase in size or the presence of new lesions on MRI. Progression is defined as the appearance of new tumors or a measurable increase in the sum of the product of the two longest perpendicular diameters of the index lesion(s) over a time period \< 12 months prior to evaluation for this study. For purposes of this study, index PN lesions will be those PNs evaluated as the most life-threatening, debilitating, cosmetically disfiguring, and/or most easily measured.
4. Prior therapy: Patients with NF1 are eligible at the time of recurrence or progression of inoperable PN. A surgical consultation should be obtained prior to enrollment on the study to evaluate if tumor resection is a feasible option. Patients will only be eligible if complete tumor resection is not feasible or if a patient with a surgical option refuses surgery. Since there is no standard effective chemotherapy for patients with NF1 and progressive PN, patients may be treated on this trial without having received prior therapy. Patients must have recovered from the toxic effects of all prior therapy before entering this study. The Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0 will be used for toxicity assessment. Recovery is defined as a toxicity grade \< 2, unless otherwise specified in the Inclusion and Exclusion Criteria. Patients must have had their last dose of radiation therapy at least 6 weeks prior to study entry, and their last dose of chemotherapy at least four weeks prior to study entry. Patients who received granulocyte-colony stimulating factor (G-CSF) after the prior cycle of chemotherapy must be off G-CSF for at least one week prior to entering this study.
5. Performance status: Patients should have a life expectancy of at least 12 months and a Lansky or Karnofsky performance score of \> 60. Patients who are wheelchair bound because of paralysis should be considered "ambulatory" when they are mobile and active in their wheelchairs rather than actually ambulatory.
6. A Pregnancy test must be negative for females of childbearing age.
7. Informed consent: All patients or their legal guardians (if the patient is less than 18 years old) must sign an approved document of informed consent indicating their understanding of the investigational nature and the risks of this study before beginning therapy. When appropriate pediatric patients will be included in all discussion in order to obtain verbal assent.
Exclusion Criteria:
1. Pregnant females are excluded
2. Patient has had treatment with an investigational agent within the past 30 days.
3. Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor or immunotherapy.
4. Inability to return for follow-up visits or obtain follow-up studies required to assess toxicity and response to therapy. | 6,707 |
Study Objectives
The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".
Conditions: Cancer, Pain, Constipation
Intervention / Treatment:
DRUG: Oxycodone, DRUG: Oxycodone/Naloxone
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
1. Male or female subjects at least 18 years or older with a diagnosis of cancer.
2. Females less than one year post-menopausal must have a negative urine pregnancy test recorded at the screening visit, be non-lactating, and willing to use adequate and highly effective method of contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (hormonal), sexual abstinence or vasectomised partner.
3. Subjects who are receiving WHO step II or Step III analgesic medication who have constipation induced, or worsened by their opioid medication, as shown by
1. the subject's medical need of regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations when not taking a laxative, respectively.
2. the subject's self-assessment that their constipation was induced or worsened by their current pre-study opioid medication.
4. Documented history of moderate to severe, chronic cancer pain that requires around-the-clock opioid therapy (starting dose at the beginning of the double-blind phase of oxycodone PR between 20 - 80 mg/day) and are likely to benefit from WHO step III opioid therapy for the duration of the study. Subjects must be willing to discontinue their current opioid analgesic routine.
5. Subjects are willing to discontinue pre-study laxative medication and take study specific laxative medication.
6. Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigators opinion are willing and able to maintain adequate hydration.
7. Subjects willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
8. Subjects already taking non-opioid analgesics and all other concomitant medications (including those for the treatment of depression) are eligible to take part in the study. However, all concomitant medications that are considered necessary for the subject's welfare should be continued at a stable dose throughout the double-blind phase of the study and under the supervision of the investigator. Regarding cyclic chemotherapy please see exclusion criteria list.
Exclusion Criteria:
1. Subjects that require a dose \>80 mg/day oxycodone PR at the start of the double-blind phase.
2. Any history of hypersensitivity to oxycodone, naloxone, bisacodyl, related products, and other ingredients.
3. Subjects with any situation in which opioids are contra-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
4. Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
5. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (\>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal).
6. Subjects with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study.
7. Subjects with uncontrolled seizures.
8. Subjects with increased intracranial pressure.
9. In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication.
10. Subjects with myxodema, not adequately treated hypothyroidism or Addisons disease.
11. Active alcohol or drug abuse and/or history of opioid abuse.
12. Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine).
13. Subjects with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related to the underlying cancer or disease progression.
14. Subjects who have a confirmed diagnosis of ongoing irritable bowel syndrome.
15. Subjects suffering from diarrhea and/or opioid withdrawal.
16. Surgery completed prior to the start of the Screening Period, or planned surgery during the study that would influence pain or bowel function during the study or preclude completion of the study.
17. Cyclic chemotherapy in the two weeks before the screening visit or planned during the core study that has shown in the past to influence bowel function. If subjects are having their first cycle of chemotherapy during the 2 weeks before the screening visit or during the double-blind phase of the study they should be excluded from the study.
18. Radiotherapy that, in the investigators opinion, would influence bowel function or pain during the double-blind phase of the study.
19. Subjects presently taking, or who have taken, naloxone 30 days prior to the start of the Screening Period.
20. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period). | 44,479 |
Study Objectives
This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.
Conditions: Recurrent Neuroblastoma
Intervention / Treatment:
BIOLOGICAL: hu14.18-IL2 fusion protein, DRUG: isotretinoin, BIOLOGICAL: sargramostim, OTHER: laboratory biomarker analysis
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* The target tumor is limited to neuroblastoma; patients must have had histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines at the time of initial diagnosis
* Patients must have resistant/refractory or recurrent neuroblastoma
* Tumor imaging and bone marrow evaluation for histologic analysis of marrow tumor cell quantity must be obtained within 3 weeks (21 days) prior to enrollment onto study and patients must have one of the following:
* Measurable tumor on magnetic resonance imaging (MRI), computed tomography (CT) scan, or x-ray defined as minimum of 20 mm in at least one dimension; measurable is defined as minimum of 20 mm in at least one dimension; for patients who are in first response (i.e., those patients with persistent sites of tumor after frontline therapy, but who have never relapsed), a biopsy of a lesion or bone marrow must demonstrate viable neuroblastoma following completion of therapy; if the lesion was irradiated, the biopsy must be done at least 4 weeks after radiation is completed
* Meta iodo benzyl guanidine I 123 (MIBG) scan with positive uptake at minimum of one site; for patients in first response, a biopsy of site must demonstrate viable tumor; if lesion was radiated, biopsy must be done at least 4 weeks after radiation completed
* Bone marrow with tumor cells seen on routine morphology (not by neuron specific enolase (NSE) staining only) of bilateral aspirate and/or biopsy on one bone marrow sample
* Patients must have a performance status of 0, 1 or 2; use Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50 for patients =\< 16 years of age
* Patients must have a life expectancy of ≥ 8 weeks
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study (4 weeks if prior nitrosourea).
* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a non-myelosuppressive biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; for information on half-lives of these agents, refer to the table provided in the following link: https://members.childrensoncologygroup.org/_files/disc/dvl/Half-lifetableforeligibility.pdf
* External beam radiation therapy (XRT): \>= 2 wks for local palliative XRT (small port); \>= 6 months must have elapsed if prior craniospinal XRT or if \>= 50% radiation of pelvis; \>= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
* Autologous stem cell transplant (ASCT): Patients are eligible \> 56 days after autologous stem cell infusion following myeloablative therapy; patients receiving an autologous stem cell infusion to support non-myeloablative therapy (including 131I-MIBG given as a single agent) are eligible at any time as long as they meet the hematologic and other organ function criteria for eligibility; patients who have received an allogenic stem cell transplant are excluded
* radioactive iodine (131 I) MIBG therapy: Patients are eligible \> 6 weeks after therapeutic 131I-MIBG
* Study specific limitations on prior therapy: Subjects who have previously received in vivo anti-GD2 monoclonal antibodies for biologic therapy or for tumor imaging, are eligible unless they have had progressive disease or a severe allergic reaction while receiving prior anti-disialoganglioside (GD2) therapy; subjects who have received autologous marrow infusions or autologous stem cell infusions using monoclonal antibody linked to beads to purge specimens, but no other form of anti-GD2 monoclonal antibody, are eligible
* Growth factor(s): Must not have received within 1 week of entry onto this study
* Steroids: Patients who require or are likely to require corticosteroid or other immunosuppressive drugs for intercurrent disease (any other significant medical problem related to or independent from the neuroblastoma or its treatment) while tentatively scheduled to be receiving treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product transfusion in order to avoid allergic transfusion reactions
* Peripheral absolute phagocyte count (APC=neutrophils + monocytes) \>= 1000/uL
* Platelet count ≥ 20,000/μL\*
* Hemoglobin ≥ 8 g/dL\*
* Transfusions are permitted to meet these platelet and hemoglobin criteria, if the patient is known to have a history of bone marrow involvement with tumor; patients with platelet counts \< 20,000/uL who are refractory to platelet transfusions are not eligible for this study; patients requiring transfusions of platelets or red blood cells (RBC) to meet eligibility criteria will not be evaluable for hematologic toxicity
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min OR serum creatinine based on age/gender as follows:
* 0.4 mg/dL (1 month to \< 6 months of age)
* 0.5 mg/dL (6 months to \< 1 years of age)
* 0.6 mg/dL (1 to \< 2 years of age)
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
* Total bilirubin =\< 1.5 times upper limit of normal (ULN)
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x upper limit of normal (ULN) for age
* Shortening fraction of \>= 27% by echocardiogram
* Ejection fraction of \>= 55% by gated radionuclide study (interleukin 2 \[IL2\] is associated with capillary leak and, at high doses, pulmonary edema)
* Corrected QT (QTC) interval \< 450 msec
* Due to risk of IL2 associated vascular leak and pulmonary edema, patients must have normal respiratory function; this is defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% on room air; if pulmonary function tests (PFTs) are performed, the forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) must be greater than 60%
* Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of CNS disease at the time of protocol enrollment; (it is currently unknown whether hu14.18-IL2 penetrates the blood brain barrier to provide effective CNS treatment)
* Patients with seizure disorders may be enrolled if on anti-convulsants and well-controlled
* CNS toxicity =\< grade 2
Exclusion Criteria:
* Females of childbearing potential must have a negative pregnancy test
* Patients of childbearing potential must agree to use an effective birth control method (as isotretinoin is known to be teratogenic)
* Female patients who are lactating must agree to stop breast-feeding
* Patients with symptoms of congestive heart failure or uncontrolled cardiac rhythm disturbance are not eligible
* Patients with symptomatic pleural effusions or ascites (requiring constant or intermittent drainage) because IL2 is associated with capillary leak are not eligible
* Patients who have had major surgery (i.e., laparotomy or thoracotomy) within the past 2 weeks are not eligible, due to the capillary leak associated with IL2
* Patients with organ allografts (including bone marrow or stem cell) due to the immune activating effects of IL2 are not eligible; patients receiving prior autologous bone marrow or stem cell re-infusions are eligible
* Patients with prior history of ventilator support related to lung injury (lung injury such as pneumonia, hemorrhagic pneumonitis, capillary leakage) are excluded
* Patients with significant serious intercurrent illnesses (any other ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and which is expected to interfere with the action of hu14.18-IL2 or to significantly increase the severity of the toxicities experienced from hu14.18-IL2 treatment are not eligible | 36,723 |
Study Objectives
Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.
Conditions: Low-Grade Lymphoma
Intervention / Treatment:
DRUG: Antineoplaston therapy (Atengenal + Astugenal)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC greater than 2,000/mm\^3
* Platelet count greater than 20,000/mm\^3
Hepatic:
* Bilirubin normal
Renal:
* Creatinine normal
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study
* No serious active infections
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since immunotherapy and recovered
* No concurrent immunomodulating agents (e.g., interferon, interleukin-2)
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy:
* At least 4 weeks since prior corticosteroids
* No concurrent corticosteroids
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* No prior antineoplaston therapy
* No other concurrent antineoplastic agents
* No concurrent antibiotics, antifungals, or antivirals | 30,526 |
Study Objectives
The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically, investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and Interferon alpha-2b (injection) can help people with advanced cases of squamous cell carcinoma of the skin. For participants that are not approved for oral capecitabine, treating physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b have been used separately to treat squamous cell carcinoma of the skin and are FDA approved in other cancer types.
Conditions: Squamous Cell Carcinoma of Skin, Carcinoma, Squamous Cell
Intervention / Treatment:
DRUG: Pegylated Interferon alpha-2b, DRUG: Capecitabine, DRUG: 5-FU
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Must have histologically or cytologically confirmed squamous cell carcinoma of the skin. Potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. Similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible.
* Must have measurable disease, defined by Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least one lesion that can be accurately measured in at least one dimension of \>10 mm by CT, MRI, or calipers
* There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. Prior topical treatment with 5-fluorouracil is permitted. Patients who are on chronic daily doses of prednisone of greater than 10 mg are excluded. There is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 21 days have passed since last administration.
* Life expectancy of greater than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (Karnofsky \>=60%
* Must have normal organ and marrow function
* Must not be candidates for curative locoregional treatments. Patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible.
* Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Have had chemotherapy or radiotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
* May not be receiving any other investigational agents
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to either 5-FU/Capecitabine or Interferon
* Uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements
* Women who are pregnant or breastfeeding
* Any heart or lung transplant patient on immunosuppressive agents. Renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis. Patients with Chronic Lymphocytic Leukemia (CLL) or other hematologic malignancies are allowed as long as they meet other criteria listed above. | 6,271 |
Study Objectives
Physical activity during chemotherapy has been shown to increase patient health and wellbeing as well as improve outcomes in breast cancer patients. The primary aim of this project is to determine the feasibility of incorporating wearable sensors into clinical care by having breast cancer patients, undergoing chemotherapy, wear a commercially available monitor (Fitbit) that tracks physical activity, sleep, and heart rate monitor.
Conditions: Breast Cancer, Physical Activity
Intervention / Treatment:
DEVICE: Fitbit
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Female
* Diagnosed with breast cancer
* Scheduled to receive chemotherapy, but has not yet started chemotherapy
* Receiving chemotherapy at a University of California, San Diego clinic
* Willingness to wear the Fitbit throughout the course of chemotherapy
* Access to a computer or Bluetooth enabled phone to sync Fitbit data
* Able to read and communicate in English
Exclusion Criteria:
• Serious physical limitation that greatly limits mobility | 39,932 |
Study Objectives
This study was carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue. Preoperative, Operative and Postoperative data were collected including postoperative measurement of drainage, date of removal of the drain, state of the wound, incidence of Seroma formation.
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: fibrin glue in breast surgery
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE | Inclusion Criteria:
* Patients with operable breast cancer
Exclusion Criteria:
* Patients who received preoperative chemotherapy and radiotherapy were exclude
* Patients with previous axillary surgery
* Patients who underwent simultaneous reconstructive surgery and breast conservative surgery
* Locally advanced breast cancer | 34,216 |
Study Objectives
The purpose of this study is to evaluate the pharmacokinetic (PK-the study of the way a drug enters and leaves the blood and tissues over time) characteristics of bortezomib when administered intravenously in Taiwanese participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Bortezomib
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Diagnosis of multiple myeloma based on the standard criteria
* Measurable, secretory multiple myeloma is defined as serum monoclonal immunoglobulin (Ig) G of \>= 10 gram per liters (g/L), serum monoclonal IgA or IgE greater than or equal to (\>=) 5 g/L, serum monoclonal IgD \>= 0.5 g/L, or serum monoclonal IgM present (regardless of level), or urine M protein of \>= 200 mg/24 hour at any time point of prior treatment
* Relapse or progression of myeloma following prior systemic antineoplastic therapy and meet the indication which had been approved in the drug leaflet. Relapse is defined as: a) reappearance of measurable disease (as defined above) following complete response (CR); b) \>= 25 percent (%) increase in serum or urine M-protein according to IMWG (International Myeloma Working group) criteria; c) development of new or worsening lytic bone disease; d) new plasmacytomas or \>=50% increase in the longest dimension of an existing plasmacytoma; e) worsening hypercalcemia (corrected serum calcium \>11.5 milligram per deciliters \[mg/dL-2.8 millimoles per liters \[mmol/L\] due to multiple myeloma
* Karnofsky performance status \>=70%
* Platelet count \>=50 × 10\^9 /L without transfusion support within 7 days before the laboratory test
Exclusion Criteria:
* More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a \>6 month treatment-free interval)
* Peripheral neuropathy or neuropathic pain of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade \>=2
* Any of the following within 3 weeks prior to enrollment in the study: antineoplastic or experimental therapy, corticosteroid use above 10 mg/day (prednisone or equivalent), or plasmapheresis
* Any of the following within 2 weeks prior to enrollment in the study: radiation therapy, major surgery (kyphoplasty is not considered major surgery)
* Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin | 16,214 |
Study Objectives
THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER
Conditions: Oral Mucositis
Intervention / Treatment:
OTHER: Oral Mucositis
Location: Turkey
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Being in the age group of 3-18 years
* Being hospitalised for chemotherapy treatment
* Not having oral mucositis
* No using another method to protect oral mucosa during the study period
* Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
* Not having intolerance to cold
Exclusion Criteria:
-Not having food in mouth | 34,183 |
Study Objectives
The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates.
The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection.
Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.
The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.
Conditions: Colorectal Cancer, Inflammatory Bowel Diseases, Microbiota, Anastomotic Leak
Intervention / Treatment:
OTHER: Fecal sample collection for analysis
Location: Canada
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
ALL
* Informed consent obtained.
* Between 18 to 90 years old inclusive.
* Group 1 (colorectal cancer patients)
* Patients with colorectal cancer confirmed with pathology results.
* Oncological colon and / or rectal resection planned and performed by a surgeon from the digestive surgery department of the CHUM.
* Group 2 (anastomotic leak patients)
* Patients with colorectal cancer confirmed with pathology and / or patients with inflammatory bowel disease.
* Patients who underwent colonic and / or rectal surgical resection, complicated by an anastomotic leak in the postoperative period.
* Group 3 ("healthy" patients)
* Patients with uncomplicated hernia pathology assessed externally in anticipation or after hernia repair surgery that does not involve gastrointestinal resection.
* Patients with no history of colorectal neoplasia or surgical resection of the gastrointestinal tract.
* Group 4 (inflammatory bowel disease patients)
* Patients with inflammatory bowel disease (IBD), waiting for elective surgery involving gastrointestinal resection.
Exclusion Criteria:
* Pregnancy.
* Class of the American Society of Anesthesiologists (ASA)\> 3.
* Chemotherapy and / or pelvic and / or abdominal radiotherapy within 6 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
* Colonoscopy within 3 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only). | 33 |
Study Objectives
The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.
Conditions: Sexual Dysfunction, Sexual Arousal Disorder, Sexual Dysfunction, Physiological, Breast Cancer, Nipple Disorder, Neuropathy, Cancer of Breast
Intervention / Treatment:
DRUG: AB-101, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Female breast cancer survivor
* Age: 18 to 70
* First diagnosed with Stage I or II breast cancer
* Have had breast surgery: nipple sparring mastectomy or lumpectomy
* At least 3 years post surgery
* Nipple neuropathy post breast surgery (change in Llikeart scale \>= 3 between pre and post surgery)
* Baseline nipple sensitivity \<=5 (likeartLikert scale)
* QoL-BC (\>=7)
* Delayed orgasm (CTCAE v4.0) Grade 2
* One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
* Able to give informed consent
* Currently in a monogamous heterosexual relationship for at least 12 months
* Sexually active within the last 30 days
* Willing to engage in sexual activity at least once a month during the duration of the study
* Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
* Willing to use an adequate method of birth control
* Able to comply with the study requirements for 8 consecutive weeks
* Able to give informed consent
Exclusion Criteria:
* Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
* Currently pregnant
* Nursing within the last 6 months prior to beginning the study
* History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
* Actively being treated for breast cancer
* Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
* Uncontrolled or severe hypertension
* Decreased oxygen in the tissues or blood
* Active inflammation of the liver
* Acute inflammation of the pancreas
* Overactive thyroid gland
* Acidosis
* Diabetes
* Spinal cord injury
* Nipple dermatitis
* Regional complex pain syndrome
* Use of any hypertensive drugs
* Use of MAO inhibitors
* Subjects assigned to interventional drug arm and failed to report an increase \>=2 from baseline in nipple sensitivity (likert scale) during phase I
* In partners: sexual dysfunction or erectile dysfunction
* Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
* Nipple dermatitis
* Regional complex pain syndrome
* Unable to provide consent or make allotted clinical visits | 15,826 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: erlotinib hydrochloride, DRUG: gemcitabine hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria Histologic or cytologic diagnosis of stage NSCLC ECOG Performance Status (PS) 0-2 Absolute Neutrophil Count (ANC) ≥ 1.5 Platelets ≥ 100,000 Hemoglobin ≥ 8.0 g/dl Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 upper limit of institutional normal (ULN) Alkaline phosphatase ≤ 4 x ULN Total Bilirubin below or equal to upper institutional normal limits Serum Creatinine ≤ 1.5 x ULN Patients may have received 1 prior treatment in the adjuvant setting, but time since prior chemotherapy must be ≥1 year. Although the protocol specifically says adjuvant therapy, we believe neoadjuvant is similar and patients who have received neo-adjuvant (pre-operative) rather than classic adjuvant (post-operative) therapy are similar and should not be distinguished. Therefore, patients may have received
1 prior treatment in the neo-adjuvant setting as well. Treated brain metastases are eligible provided the patient is asymptomatic and meets the above criteria, including PS. Measurable disease by RECIST criteria Ability to give informed consent
Exclusion Criteria Patients with a history of severe hypersensitivity to gemcitabine. Incompletely healed from previous oncologic or other major surgery. Pregnancy or breast feeding (women of childbearing potential are not expected to be enrolled in this study given minimum age) Patients with severe co-morbid illness. Patients unable to participate in the QOL assessments. | 5,233 |
Study Objectives
To assess the safety and efficacy of PF-00299804 in patients with advanced lung cancer.
Conditions: Carcinoma, Non Small Cell Lung
Intervention / Treatment:
DRUG: PF-00299804
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model:
Masking: NONE | Inclusion Criteria:
* Advanced NSCLC
* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib or gefitinib
* Prior treatment with no more than two chemotherapy regimens, including adjuvant treatment
* Measurable disease
Exclusion Criteria:
* Chemotherapy, radiotherapy, biological or investigational agents within 4 weeks of baseline disease assessment
* Patients who lack of tolerance of erlotinib therapy
* Patients with known brain Metastases
* Patients with demonstrated history of or presence of interstitial lung disease. | 37,739 |
Study Objectives
The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.
Conditions: Prostate Cancer
Intervention / Treatment:
DEVICE: MR-guided in-bore prostate biopsy, DEVICE: MRI/US fusion-guided prostate biopsy
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* At least one prior negative prostate biopsy
* Prostate-specific antigen (PSA) \> 4 ng/ml
Exclusion Criteria:
* Known prostate cancer
* Contraindications against MRI
* Contraindications against prostate biopsy | 1,550 |
Study Objectives
Background:
* Flutamide is an approved drug for prostate cancer that blocks the effects of testosterone on prostate cancer cells and may slow the progression of the disease.
* The vaccine in this study consists of a priming vaccine called PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM (triad of costimulatory molecules), made from vaccinia virus, and a boosting vaccine called PROSTVAC-F/TRICOM, made from fowlpox virus. DNA (Deoxyribonuceic acid) is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA) a protein that is normally produced by the patients tumor cells.
* GM-CSF (granulocyte macrophage colony stimulating factor), given along with the vaccine, is a chemical that boosts the immune system. It is used in this study to try to increase the usefulness of the vaccine by increasing the number of immune cells at the vaccination site.
Objectives:
-To determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with prostate cancer.
Eligibility:
* Patients 18 years of age and older with androgen-insensitive prostate cancer that has not spread beyond the prostate gland.
* Patients with a rising PSA (prostatic specific antigen) who have already been treated with anti-iandrogen therapy (either bicalutamide or nilutamide).
Design:
* There are two treatment groups in this study. Group A receives only flutamide; group B receive flutamide plus vaccine.
* Patients in both groups receive flutamide by mouth three times a day.
* Patients in group B receive PROSTVAC-V/TRICOM on day 1 and PROSTVAC-F/TRICOM on day 29 and again every 4 weeks. All vaccines are given as injections under the skin.
* Patients have blood tests for PSA levels every month and scans every 3 months until the disease worsens.
* After 3 months of therapy, patients receiving in group A (flutamide alone) may cross over to receive vaccine if they develop a rising PSA and scans show no sign of disease spread. Patients in group B (flutamide plus vaccine) stop flutamide and may continue vaccine therapy. At this point patients may continue to receive treatment until the disease progresses or PSA levels rise....
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Sargramostim (GM-CSF, Leukine), DRUG: Flutamide (Eulexin), BIOLOGICAL: PROSTVAC-F/ TRICOM, BIOLOGICAL: PROSTVAC-V/TRICOM
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | * INCLUSION CRITERIA:
A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the: National Institutes of Health (NIH) Clinical Center prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologists report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
B. Must have non-metastatic androgen insensitive prostate cancer with a rising PSA (prostatic specific antigen) with castrate levels of testosterone and no evidence of metastatic disease on CT (computed tomography) scan or bone scan. A rising PSA is defined as two consecutively rising PSA levels, separated by at least 1 month apart, with the last measurement that is greater than 1ng/ml. Patients on nilutamide therapy must undergo nilutamide withdrawal for at least 4 weeks and still show evidence of a rising PSA. Following treatment with bicalutamide, patients must undergo withdrawal for at least 6 weeks and still show evidence of a rising PSA.
C. Life expectancy greater than or equal to 6 months.
D. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
E. No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy.
F. Hematological eligibility parameters:
* Granulocyte count greater than or equal to 1,500/mm(3).
* Platelet count greater than or equal to 100,000/mm(3)
* Hgb (Hemoglobin) greater than or equal to 9 Gm/dL
* Lymphocyte count greater than or equal to 500/mm(3).
G. Biochemical eligibility parameters (within 16 days of starting therapy)
-Hepatic function: Bilirubin less than or equal to 1.5 mg/dl, OR patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL, AST (aspartate aminotransferase) and ALT (alanine aminotransferase) less than 2.5 times upper limit of normal
H. No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.
I. Willing to travel to the NIH for follow-up visits.
J. 18 years of age or greater.
K. Able to understand and sign informed consent.
L. Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last vaccination therapy. Patients must be willing to remain on chemical castration therapy, unless they have had surgical castration.
M. Patients must have recovered from acute toxicities related to prior therapy or surgery.
N. Parameters for assessment of baseline renal function:
Serum creatinine less than or equal to 1.5 times the upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.
EXCLUSION CRITERIA:
A. Patients should have no evidence of being immunocompromised as listed below.
* Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects.
* Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. Nasal or inhaled steroid use is permitted.
* Patients who have undergone allogenic peripheral stem cell transplantation or solid organ transplantation requiring immunosuppression.
B. Patients who test positive for active Hepatitis B or Hepatitis C infection.
C. Patients should have no autoimmune diseases that have required treatment such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, active Grave's disease.
D. History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen.
E. Do not administer the recombinant vaccinia vaccine if the recipient, or for at least three weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact) are: persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV (human immunodeficiency virus) infection.
F. Serious intercurrent medical illness (e.g., one that requires treatment) which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
G. Patients with cardiac disease that have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible.
H. Patients with a history of congestive heart failure or who have objective evidence of congestive heart failure by physical exam or imaging are not eligible.
I. Patients with pulmonary disease that have fatigue or dyspnea with ordinary physical activity are not eligible.
J. Concurrent chemotherapy.
K. No known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis.
L. Patients with a serious hypersensitivity reaction to egg products are not eligible.
M. Prior splenectomy.
N. Patients who have received prior flutamide therapy in the last year. (Patients treated with flutamide in the neoadjuvant or adjuvant setting or those previously treated with flutamide who did not have a rising PSA on treatment would be allowed to enroll on the protocol.) | 1,888 |
Study Objectives
To assess recruitment rate, attrition, compliance with weekly exercise, smoking cessation, and quality of life with a multimodal prehabilitation protocol for women with breast cancer undergoing neo-adjuvant chemotherapy for breast cancer.
Conditions: Breast Cancer, Rehabilitation, Neoadjuvant Therapy, Feasibility Studies
Intervention / Treatment:
COMBINATION_PRODUCT: Prehabilitation
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* 18 years and older, able to give consent, ECOG 0-1
Exclusion Criteria:
* pregnant, \> 80 years, medical contraindications to exercise. History of severe and persistent mental illness, cognitive impairment, recent suicide attempts or \>11 on "Hospital Anxiety and Depression Scale". If very active (\> 24) on the Godin-Shephard scale. | 36,171 |
Study Objectives
The goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypT0N+ patients in patients with esophageal squamous cell carcinoma. The main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.
Conditions: Esophageal Squamous Cell Carcinoma
Intervention / Treatment:
OTHER: non-intervention
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* histologically confirmed potentially resectable ESCC, clinical stage T1-4N0-1M0 (stage I-III) according to the American Joint Committee on Cancer 6th edition staging criteria.
Exclusion Criteria:
* incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data. | 17,484 |
Study Objectives
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.
Conditions: Metastatic Non-small Cell Lung Cancer, Locally Advanced Urothelial Cancer, Metastatic Urothelial Cancer, Unresectable Melanoma, Metastatic Melanoma, Locally Advanced Renal Cell Carcinoma, Metastatic Clear-Cell Renal Cell Carcinoma
Intervention / Treatment:
DRUG: Retifanlimab
Location: Poland, Austria, Hungary, United States, Romania, Spain, France, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy.
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
* Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug.
* Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
* Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy; 6 months for thoracic region radiotherapy that is \> 30 Gy.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
* Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
* Laboratory values outside the protocol-defined range at screening.
* Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg of prednisone or equivalent).
* Evidence of interstitial lung disease or active noninfectious pneumonitis.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
* Active infections requiring systemic therapy.
* Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
* Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Impaired cardiac function or clinically significant cardiac disease.
* Is pregnant or breastfeeding.
* Has received a live vaccine within 28 days of the planned start of study drug. | 22,975 |
Study Objectives
The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.
Conditions: Patient With Prostate Cancer
Intervention / Treatment:
PROCEDURE: standard lymphadenectomy, PROCEDURE: lymphadenectomy radio-isotope method
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Subject man, whose age is greater than or equal to 18 years
* Carrier of cancer intermediate risk non-metastatic prostate or high relapse
* Subject with an initial balance sheet expansion, regional and general negative by Scanner, abdominopelvic MRI or bone scan,
* Subject has undergone a medical examination in connection with the study,
* Topic for which a radical prostatectomy is considered curative purposes,
* Supported by Subject surgical teams involved in the study,
* Topic affiliated to a social security scheme,
* Subject who signed informed consent.
Exclusion Criteria:
* Subject man, whose age is less than 18 years
* Subject who have received hormone therapy or radiation therapy for prostate cancer
* Subject who had surgery for prostate adenoma (transurethral resection or open surgery) because of potential difficulties injection of radioactive tracer in the gland,
* Subject has a history of pelvic surgery or radiotherapy,
* Subject with inguinal hernia repair history of laparoscopic,
* Subject refusing blood transfusions,
* Subject is not agreeing to participate in this study and did not sign the informed consent. | 5,221 |
Study Objectives
This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.
Conditions: Non Small Cell Lung Cancer, Immunotherapy, Chemotherapy, Tumour, Residual
Intervention / Treatment:
DRUG: Timing of drug administration
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
* early-stage NSCLC patients who were initially unresectable.
* 18 years of age or older.
* Karnofsky performance status (KPS) score of 100 or 90.
Exclusion Criteria:
* Patients with stage IV NSCLC
* Patients with known ALK translocations or EGFR mutations.
* Karnofsky performance status (KPS) score \<90. | 19,543 |
Study Objectives
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.
Conditions: Palliative Care
Intervention / Treatment:
RADIATION: Short course radiotherapy
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* histologically proven locally advanced or metastatic H\&N cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \< 3
Exclusion Criteria:
* prior RT to the same region. | 32,489 |
Study Objectives
The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: Durvalumab, DRUG: Dabrafenib, DRUG: Trametinib
Location: Canada, United States, Italy, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Adults \>= 18 years old
* Histologically confirmed cutaneous melanoma that is either Stage IIIc (unresectable) or Stage IV (metastatic) and determined to be BRAF V600E or V600K mutation-positive (cohort A) or mutation-negative (cohorts B and C)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by radiographic or physical examination
* Adequate organ and marrow function
* Willingness to provide consent for biopsies positive or BRAF WT measurable disease and adequate organ and marrow function
Exclusion Criteria:
* Prior treatment with a BRAF inhibitor or MEK inhibitor
* Any prior Grade \>= 3 immune-related adverse event while receiving immunotherapy
* Active or prior documented autoimmune disease within the past 2 years
* History of or current risk for retinal vein occlusion (RVO) or central serous retinopathy (CSR)
* History of or current cardiovascular risk including myocardial infarction, \>= Class II congestive heart failure, uncontrolled arrhythmias, or refractory hypertension
* Active, untreated central nervous system (CNS) metastases
* Women who are pregnant or lactating | 43,032 |
Study Objectives
Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4.
Objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in TC patients treated with (B)EP.
Study design: A single centre, prospective, paired observational pharmacokinetic study in 12 patients with TC who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard BEP or EP-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. The effect of aprepitant on etoposide will be investigated within the same patient. In this study the patient will serve as its own control.
Conditions: Testicular Cancer
Intervention / Treatment:
OTHER: Blood sampling - Pharmacokinetic assessment
Location: Netherlands
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients with TC who will start or already started treatment with (B)EP
* Age of at least 18 years
* Patients from whom it is possible to collect blood samples
* Patients who are able and willing to give written informed consent prior to screening
Exclusion Criteria:
* Patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong CYP3A4 inhibitor OR weak, moderate and strong inducers of CYP3A4 according to the table based on the Flockhart table (Appendix 1) less than 30 days prior to study or during the study.
* Creatininclearance \<40 ml/min
* Severe liver dysfunction (bilirubin\>ULN) | 13,797 |
Study Objectives
The purpose of this study is to study if a patients follows an exercise program specifically designed for them during the time of their treatment after surgery. Their ability to follow the program and its influence on their weight maintenance and early post-operative lymphedema rates will also be studied. Lymphedema is a condition in which excess fluid collects in tissue and causes swelling of the arm(s).
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients will be eligible if they have any of the following surgical procedures performed by an attending on the Breast Service:
SLNB alone Axillary lymph node dissection (ALND) alone Total Mastectomy TM (+/- reconstruction) with SLNB or ALND Breast conserving therapy (BCT) with SLNB or ALND
* Age \> 18 years
* Planned to undergo adjuvant post-operative chemotherapy with or without radiation at MSKCC and have not yet started chemotherapy
Exclusion Criteria:
* Undergoing TM or BCT without SLNB
* Having had prior breast cancer treated with surgery
* Unable to participate in a exercise program related to other medical problems
* More than 8 weeks post surgery.
* Having a concurrent cancer in addition to breast cancer
* Who have had any type of chemotherapy in the past two years | 24,551 |
Study Objectives
Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP) chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal squamous cell carcinoma and make prognostic scoring system. The present study represents the largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC. Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be actively pursued.
Conditions: Metastatic Esophageal Squamous Cell Carcinoma
Intervention / Treatment:
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* recurrent, metastatic esophageal SCC
* received either FP or XP as first-line chemotherapy.
Exclusion Criteria: | 2,227 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma.
Conditions: Melanoma (Skin)
Intervention / Treatment:
DRUG: irofulven
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven stage IV malignant melanoma No prior chemotherapy OR No more than 1 prior chemotherapy containing regimen Measurable disease Brain metastasis allowed if adequately treated
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from any prior therapy No other concurrent therapy | 5,471 |
Study Objectives
This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: peroperative scintillating probe, DEVICE: operative gamma camera
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* infiltrative breast cancer
* no suspect axillary lymph node
* no previous radiotherapy
* no previous chemotherapy
* no previous breast surgery | 28,844 |
Study Objectives
The purpose of this study is to determine if the combination of Taxotere and exisulind is an effective and safe treatment for patients with advanced NSCLC who have failed a prior platinum-containing regimen.
Conditions: NSCLC
Intervention / Treatment:
DRUG: Exisulind
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
Histologically documented advanced cancer or advanced platinum-refractory non-small cell lung cancer. Platinum refractory defined as progressive disease during a platinum regimen or within 6 months following treatment.
Negative serum pregnancy test, if fertile female. Have not taken sulindac (Clinoril®) on regular basis for any indication for one week prior to enrollment and willing to remain off of sulindac for the duration of the study.
\> 18 years or of legal age. Male patients, or non-pregnant and non-lactating female patients either using adequate birth control (oral contraceptives or Provera), surgically sterile or post-menopausal.
Willingness to remain off chronic NSAIDs (with the exception of ibuprofen, naproxen, or aspirin) for duration of the study. Low dose aspirin for cardiovascular prevention is acceptable.
No treatment with any other chemotherapy or radiotherapy within 2 weeks prior to entering the study.
Exclusion Criteria:
Any condition or any medication which may interfere with the conduct of the study.
Known hypersensitivity to sulindac (Clinoril®) or taxanes. Use of an investigational medication or device within one month of initiating study therapy. | 2,207 |
Study Objectives
The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.
Conditions: Acute Lymphoblastic Leukemia
Intervention / Treatment:
DRUG: 6-Mercaptopurine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* No clinically significant abnormal findings on physical examination, medical history, or clinical laboratory results.
* Must voluntarily consent.
Exclusion Criteria:
* Must not have a known history of thiopurine methyltransferase deficiency or family history.
* Must not have a history of elevated uric acid or gout.
* Must not be currently using allopurinol. | 34,458 |
Study Objectives
This is a prospective diagnostic performance study which compares three new imaging methods with the current standard imaging method for the diagnosis of metastatic lymph nodes.
Conditions: Surgically Staged Endometrial and Cervical Carcinoma, Cervical Cancer: Invasive Disease, FIGO Stage 1B1 or Higher, Endometrial Cancer, Stage 1A With Myometrial Invasion or Any Higher Stage and Grade 3, Stage 1A With Myometrial Invasion or Any Other Higher Stage and Serous Papillary or Clear Cell Sub-types, Stage II Disease or Above and Any Histology Grade
Intervention / Treatment:
DIAGNOSTIC_TEST: Diffusion-weighted MRI, DIAGNOSTIC_TEST: Fluorodeoxyglucose-18-PET/CT, DIAGNOSTIC_TEST: Fluoro-ethyl-coline-PET/CT
Location: United Kingdom
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Females 18 years or older; (no upper limit).
2. Patients with histologically confirmed cancer of the cervix or endometrium.
1. In patient with cervix cancer, there must be confirmation of invasive disease; FIGO stage 1B1 or higher FIGO stage demonstrated clinically and/or on MRI. In patients with advanced disease being considered for chemoradiotherapy treatment, patients may be considered for entry if nodal lymphadenectomy is being used to inform radiotherapy planning;
2. In patients with endometrial cancer, a) stage 1A with myometrial invasion or any higher stage and grade 3 b) stage 1A with myometrial invasion or any other higher stage and serous papillary or clear cell sub-types
3. stage II disease or above and any histology grade The MDT decision may be based on the combination of tumour characteristics on histology, clinical and imaging findings.
3. No contra-indication to FDG-PET/CT, FEC-PET/CT or MRI.
4. Fit for surgical lymphadenectomy, as determined by the local MDT. The patient should also be considered fit for extended field radiotherapy in cases where lymphadenectomy is being undertaken to inform radiotherapy planning.
The extent of lymph node dissection will be made by the local multidisciplinary team, based on the presence of risk factors for lymph node metastases, according to the protocol. Patients must be considered fit to undergo lymph node dissection.
5. Able and willing to give written informed consent and to comply with the study protocol procedures
Exclusion Criteria:
1. Known contra-indication to MRI or PET/CT scan.
2. Known allergy to FDG or FEC.
3. Not considered fit for lymphadenectomy (open or laparoscopic) or, where appropriate, radiotherapy, as determined by the local MDT.
4. If the patient is pregnant or breast-feeding.
5. Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control) from the time consent is signed until 6 weeks after the last PET/CT scan unless undergoing hysterectomy.
Note: subjects are not considered of childbearing potential if they are surgically sterile (they have undergone bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal
6. Females of childbearing potential must have a negative pregnancy test within three weeks prior to being registered for the study.
7. Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP). If patient's have recently completed a CTIMP trial they must have had their last dose(s) of study drug prior to their first imaging procedure on the MAPPING study.
8. Participation in another clinical trial (CTIMP or non-CTIMP) where the protocol contains imaging procedures that would occur during the MAPPING study.
9. Medical or psychiatric illness, which makes the patient unsuitable or unable to give informed consent. | 12,929 |
Study Objectives
This is a Phase III trial comparing hepatic intra-arterial injection of Yttrium-90 microspheres (selective internal radiation \[SIR\] spheres) versus infusional intravenous (IV) 5FU in colorectal cancer metastatic to the liver only and refractory to standard IV chemotherapy.
Conditions: Colorectal Neoplasm, Secondary Malignant Neoplasm of Liver
Intervention / Treatment:
DEVICE: SIR Spheres intra-arterial hepatic
Location: Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Histologically proven colorectal adenocarcinoma, metastatic to the liver only.
* Failure of prior chemotherapy for advanced colorectal cancer.
* Adequate laboratory values of hematologic, renal and liver function
* World Health Organization (WHO) performance status (PS) \<= 2
* Written consent
Exclusion Criteria:
* Pregnant or lactating patients
* Other tumor type than adenocarcinoma (leiomyosarcoma; lymphoma).
* Patients with cirrhosis or other chronic liver disease
* Thrombosis of the hepatic main artery of the portal vein
* Lung shunting \> 20% as determined by nuclear medicine breakthrough scan
* Patients with serum bilirubin \> 1.0 x upper limit of normal (ULN) or with AST and/or ALT and/or alkaline phosphatase \> 5 x ULN
* Patients with concurrent or within 4 week period administration of any other experimental drugs.
* Other serious illness or medical conditions. | 9,023 |
Study Objectives
MYASTHENIA GRAVIS (MG) is an autoimmune disease characterized by varying degrees of muscle weakness and fatigability worsened with exertion and relieved with rest。Thymectomy plays an important role in the management of these patients because a consistent association between myasthenic and thymic pathology has been recognized.The need for prolonged mechanical ventilation in these patients after thymectomy is determined by their preoperative condition and various perioperative risk factors. Leventhal et al proposed a preoperative scoring system to predict the need for postoperative mechanical ventilation in myasthenic patients undergoing thymectomy based on the following 4 criteria: duration of MG, chronic respiratory disease, dose of pyridostigmine, and vital capacity. However, some investigators discovered that the Leventhal criteria may not be the sole benchmark and that other criteria such as severity of myasthenia,history of myasthenic crisis, and presence of thymoma may be more important in predicting the necessity for prolonged mechanical ventilation after thymectomy. Naguib et al described multivariate determinants of the need for postoperative ventilation after thymectomy in MG patients predominantly on the basis of pulmonary function tests. In addition, the prevalence and presentation of MG may be variable among different ethnic groups. However, there are very few large studies investigating the determinants of prolonged mechanical ventilation after thymectomy. The authors describe the parameters associated with prolonged mechanical ventilation after trans-sternal thymectomy at their institution.
Conditions: Myasthenia Gravis Associated With Thymoma
Intervention / Treatment:
OTHER: extubation
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* myasthenia gravis patients after thymectomy
Exclusion Criteria:
* not extubation | 32,297 |
Study Objectives
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine and external-beam radiation therapy in treating patients with cancer that has spread to the brain.
Conditions: Brain and Central Nervous System Tumors
Intervention / Treatment:
DRUG: Cytochlor, DRUG: Tetrahydrouridine, RADIATION: Radiation Therapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Diagnosis of metastatic cancer to the brain by contrast-enhanced MRI or CT scan
* Eligible for whole-brain radiotherapy (WBRT)
* Patients treated with prior surgery are eligible if WBRT is to be used post operatively
* Not planning to be treated with stereotactic radiosurgery
* No leptomeningeal metastasis documented by contrast-enhanced MRI/CT scan or cerebrospinal fluid evaluation
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Karnofsky performance status (PS) 70-100% or ECOG PS 0-1
* Leukocytes ≥ 3,000/µL
* Absolute neutrophil count \> 1,500/µL
* Platelet count \> 100,000/µL
* Total bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \> 60 mL/min
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Exclusion criteria:
* Uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or lactating
* Alcohol dependence
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy to the brain
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or other experimental medication
* No other concurrent anticancer therapy outside the protocol
* Systemic therapy one month before or after brain radiotherapy is allowed
* No concurrent heparin or coumadin | 37,241 |
Study Objectives
Stage I:preoperative therapy
* Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy
* Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone;
* A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer
Conditions: Gastroesophageal Junction Adenocarcinoma
Intervention / Treatment:
DRUG: Oxaliplatin; Capecitabine, OTHER: Oxaliplatin; Capecitabine; concurrent radiotherapy
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)
2. Histologically confirmed primary adenocarcinoma
3. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0,
4. ECOG performance status ≦2
AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia.
The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus,which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above;
* AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction;
* AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below.
Exclusion Criteria:
1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
2. Patients with primary carcinomas of the esophagus.
3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
4. Patients with evidence of metastatic disease are not eligible.
5. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
6. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
7. Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
8. History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product - | 11,378 |
Study Objectives
The Sharing Our Strength study is being conducted to help us understand people's experiences with hematopoietic stem cell transplantation and to test a new program designed to help people recover physically and emotionally after transplant.
Conditions: Leukemia, Acute Leukemia, Acute Lymphocytic Leukemia, Multiple Myeloma, Hematological Cancers, Psychological Distress
Intervention / Treatment:
BEHAVIORAL: Writing A (Experimental informative writing), BEHAVIORAL: Writing B (Experimental noninformative writing), BEHAVIORAL: Writing C (Control informative writing), BEHAVIORAL: Writing D (Control noninformative writing)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: DOUBLE | Inclusion Criteria:
* Be a transplant survivor who is 9 months to 3 years beyond transplant and not currently relapsed. and not currently relapsed
* Be at least 18 years old now (and at least 16 when they had their transplant)
* Speak English
* Have telephone service
Exclusion Criteria:
* None | 23,336 |
Study Objectives
The purpose of the study is to assess the survival of patients treated with Litx™ versus standard of care therapies in the treatment of unresectable hepatocellular carcinoma (HCC), and to demonstrate the safety of Litx™ therapy.
Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tissue inside the body.
Conditions: Carcinoma, Hepatocellular, Liver Neoplasms
Intervention / Treatment:
DRUG: Talaporfin sodium, DEVICE: Interstitial Light Emitting Diodes, PROCEDURE: Percutaneous placement of device in the liver, PROCEDURE: Standard Care
Location: Philippines, Korea, Republic of, Hong Kong, Thailand, Malaysia, India, Singapore, Croatia, Sweden, Poland, Serbia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* A diagnosis of primary Hepatocellular Carcinoma (HCC), established by any one of the following criteria in a clinical setting suggestive of HCC: A. Two different imaging techniques with characteristics that suggest HCC; B. Combination of one imaging technique that suggests HCC and serum AFP level \>400 ng/mL; C. Histological evidence of HCC
* ECOG Performance Status 0-2
* Life expectancy of at least 16 weeks
* Patients may have received previous antineoplastic therapy; at least 3 weeks must have elapsed since the completion of any prior therapy and the patient must have recovered from acute side effects.
* Understanding and ability to sign written informed consent
* 18 years of age or more
* Adequate hematologic, liver and renal functions as evidenced by the following: WBC \>= 2,400/mm³ ; Platelet Count \>= 75,000/µl ; Hemoglobin \>= 9.4 gm/dL ; PT and PTT \<= 1.5 Control ; SGOT, SGPT \<= 5 × ULN ; Bilirubin \<= 2.5 × ULN ; Alk Phos \<= 3 × ULN ; Creatinine \<= 2.5 mg/dL (SI: 221 mmol/L) ; Albumin \>= 2 g/dL
Exclusion Criteria:
* Patients who are candidates for surgery with curative intent are not eligible
* Patients with 6 or more lesions are not eligible
* Patients with greater than 50% of parenchyma disease involvement are excluded
* Patients with Child-Pugh C cirrhosis are excluded
* Patients with diffuse HCC are excluded
* Patients with grade 3 ascites are excluded
* Evidence of major vessel invasion or extrahepatic disease is excluded. Lymph node involvement in the hilum region of the liver is eligible if the nodes do not exceed 2 cm.
* Known sensitivity to porphyrin-type drugs or known history of porphyria are exclusionary
* Pregnancy or breast-feeding patients are excluded. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
* Concurrent participation in another clinical trial involving experimental treatment is excluded
* Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded. | 6,165 |
Study Objectives
This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.
Conditions: MPN (Myeloproliferative Neoplasms)
Intervention / Treatment:
Location: United States, Puerto Rico
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age ≥18 years
* Diagnosis of Polycythemia Vera (PV)
* Willing and able to provide written informed consent
* Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
* Under the supervision of a physician for the current care of PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide
Exclusion Criteria:
* Participation in an active clinical trial in which the study treatment is blinded
* Life expectancy \<6 months
* Diagnosis of myelofibrosis (MF) \[including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)\]
* Diagnosis of secondary Acute Myeloid Leukemia (AML)
* Diagnosis of Myelodysplastic Syndrome (MDS)
* History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months
* Splenectomy | 32,405 |
Study Objectives
The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients.
Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.
In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
Conditions: Colon Polyps and Adenomas, Colon Cancer
Intervention / Treatment:
DEVICE: Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system
Location: United States, Netherlands, Israel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Subject between the ages of 18 and 70
* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception
Exclusion Criteria:
* Patients with a history of colonic resection;
* Patients with known (or newly diagnosed) inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected chronic stricture potentially precluding complete colonoscopy;
* Patients with diverticulitis or toxic megacolon;
* Patients with a history of radiation therapy to abdomen or pelvis;
* Patients with acute lower GI bleeding
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study. | 9,299 |