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Study Objectives
According to the data from the World Health Organization, approximately 14 million people are diagnosed with cancer every year, and this number is expected to increase further in the next 10 years. Multidisciplinary treatment consisting of chemotherapy, radiotherapy and surgery is applied in childhood cancers. In chemotherapy, the target is cancerous cells, but high doses of chemotherapeutic agents do not have selectivity. Intact tissue cells are also affected by this cytotoxicity. Mucositis develops in the patient, especially as a result of the mucosal cells being affected. Mucositis is defined as damage to the mucosa lining the oral cavity, pharynx, larynx, oesophagus and gastrointestinal tract due to cancer treatment. It is one of the most important side effects of both chemotherapy and radiotherapy. This study is carried out to determine the effectiveness of propolis in preventing the formation of oral mucositis due to multiple use of chemotherapeutic drugs.
Conditions: Oral Mucositis
Intervention / Treatment:
BIOLOGICAL: propolis, BIOLOGICAL: Placebo
| Inclusion Criteria:
* Volunteering to participate in the study
* Receiving chemotherapy treatment for lymphoproliferative malignant disease (leukaemia, lymphoma) or other childhood solid tumour (such as central nervous system tumour, neuroblastoma, osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumours)
* Being between the ages of 2-18 (Although there is no harm in using propolis, it is inconvenient for children under the age of 2 to use honey and its by-products due to botulism)
* No development of oral mucositis
* The child who does not smoke
Exclusion Criteria:
* The patient does not receive head and neck RT (increases the incidence of oral mucositis by 40%).
* The patient is allergic to bee products.
* Exclusion Criteria and Practices in this Case:
* Development of an allergic reaction to propolis (Applied oral care protocol is stopped, removed from the sample)
* Starting RT
* The child's need for MV support | 18,387 |
Study Objectives
RATIONALE: A stress management intervention may be more effective than usual care in improving quality of life in caregivers of patients undergoing bone marrow transplant.
PURPOSE: This randomized phase III trial is studying a stress management intervention for caregivers of patients undergoing bone marrow transplant.
Conditions: Hematopoietic/Lymphoid Cancer
Intervention / Treatment:
DEVICE: Paced respiration as part of PEPRR, BEHAVIORAL: PEPRR
| Inclusion Criteria:
* DISEASE CHARACTERISTICS (Meets all of the following criteria):
* Patient undergoing allogeneic bone marrow transplantation (BMt)
* Primary caregiver of a BMT patient
* Has provided care for the patient for at least 50 days of the required 100 days of caregiving following transplant (e.g., 50% of the total time)
* PATIENT CHARACTERISTICS:
* Able to read and speak English
* Has telephone access
* No serious medical condition likely to influence immune and neuroendocrine parameters (caregiver)
* Alcohol consumption limited to < 2 drinks/day (caregiver)
* No history of a psychiatric illness unrelated to the experience as a caregiver within the past 18 months (caregiver)
* No history of a psychiatric illness unrelated to the BMT within the past 18 months (patient)
Exclusion Criteria:
* PRIOR CONCURRENT THERAPY:
* No concurrent steroid medications (caregiver) | 32,731 |
Study Objectives
This study is a prospective, multicenter, observational study to characterize utilization patterns of the FoundationOne™ test by oncologists under conditions of routine clinical practice in the US. The study will also examine impact of test results on subsequent clinical decisions regarding choice of therapy. The planned duration of the study is at least 2 years with 1 year for patient recruitment and a minimum 1-year follow-up period for each patient. Any patient for whom the treating physician has ordered a FoundationOne™ test and a report is delivered is eligible for participation on the study. Eligible patients from participating sites will be enrolled sequentially during the 1-year enrollment period. Sites will be required to maintain an enrollment log of all patients for whom the FoundationOne™ test has been ordered and document patient disposition and reasons for non-participation. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol. Informed consent will be obtained from eligible patients prior to study entry.
Conditions: Cancer, Neoplasm Metastasis, Tumor
Intervention / Treatment:
| Inclusion Criteria:
The FoundationOne test was ordered by the treating physician under routine clinical practice
* Age ≥ 18 years
* Patient willing and able to provide informed consent
* Informed consent date is at least one day prior to the FoundationOne test report date
Exclusion Criteria:
There are no exclusion criteria for this study | 25,124 |
Study Objectives
The purpose of this study is to determine the effects of tivantinib on the pharmacokinetics of omeprazole, s-warfarin, caffein, midazolam, or digoxin in patients with cancer.
Conditions: Solid Tumors
Intervention / Treatment:
DRUG: tivantinib, DRUG: omeprazole, DRUG: s-warfarin, DRUG: caffeine, DIETARY_SUPPLEMENT: vitamin K, DRUG: digoxin, DRUG: midazolam
| Inclusion Criteria:
* Have a histologically or cytologically confirmed advanced solid tumor at screening;* Male or female ≥ 18 years of age;* Subjects (male and female) of childbearing potential must agree to use double barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug. In addition, all female subjects of childbearing potential must have a negative pregnancy test result before initiating study treatment;* An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;* Adequate bone marrow, liver, clotting, and renal function, defined as:
Platelet count ≥ 100 x 10\^9/L, Hemoglobin (Hb) ≥ 9.0 g/dL, ANC ≥ 1.5 × 109/L, Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN for subjects with liver metastases), International normalized ratio ≤ 1.5, Serum creatinine ≤ 1.5 x ULN;* Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or chronic co-morbidity that would interfere with therapy; and* Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB approved ICF (including HIPAA authorization, if applicable) before performance of any study specific procedures or tests.
Exclusion Criteria:
* History of cardiac disease:
* Active coronary artery disease, defined as myocardial infarction (MI), unstable angina, coronary artery bypass graft, or stenting within 6 months prior to study entry (an MI that occurred > 6 months prior to study entry is permitted);
* Evidence of uncontrolled symptomatic bradycardia or other cardiac arrhythmia defined as ≥ Grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, or uncontrolled hypertension;* Active, clinically serious infection(s) defined as ≥ Grade 2 according to NCI CTCAE, version 4;* Family or personal history of coagulopathy;* History of hypersensitivity or adverse reactions to omeprazole, digoxin, warfarin, caffeine, midazolam, or vitamin K;* Known metastatic brain or meningeal tumors, unless the subject is > 3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of first dose of study drug;* Pregnant or breastfeeding;* Any major surgical procedure within 3 weeks prior to first dose of study drug;* Significant gastrointestinal disorder(s), in the opinion of the Investigator (eg, Crohn's disease, ulcerative colitis, extensive gastric resection);* Received anti-cancer therapy, including antibody, retinoid, or hormonal treatment (except megestrol acetate as supportive care), and radiation, within 3 weeks before dosing. Prior and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted;* Received any other investigational drug within 3 weeks prior to dosing;* Received tivantinib as prior therapy;* Substance abuse or medical, psychological, or social conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results;* Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection;* Inability to swallow oral medications that could interfere with the absorption of tivantinib;* Administration or possibility of initiating or continuing any treatment with any known Cytochrome P450 (CYP)3A4, CYP2C19, CYP1A2, CYP2C9, and P-glycoprotein enzyme-altering drugs (inducer or inhibitor) or non-drug agents or systemic gastric pH modifiers (ie, ranitidine, proton pump inhibitors etc) within the 14 days prior to dosing and/or during the primary objective phase after initiation of the study treatment; or* Clinical diagnosis of hepatic impairment from chronic liver cirrhosis with confirmation by either previous liver biopsy or imaging, regardless of liver function test results at screening. | 31,287 |
Study Objectives
A multicenter real-world study was conducted to gather clinicopathological data from patients with HER2-positive metastatic breast cancer who were treated with inetetamab between 2022 and 2023. The study aimed to estimate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs) associated with inetetamab therapy.
Conditions: HER2-positive Metastatic Breast Cancer
Intervention / Treatment:
DRUG: inetetamab
| Inclusion Criteria:
* An age of at least 18 years or older* Pathologically diagnosed with HER2-positive recurrent or metastatic breast cancer* Having at least one measurable lesion as defined* Receiving inetetamab-based therapy in the recurrent or metastatic stage* Having traceable medical history records
Exclusion Criteria:
* Pregnant or lactating women* Patients with other conditions deemed unsuitable for participating in this study by the researcher | 8,151 |
Study Objectives
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.
Conditions: Breast Neoplasms
Intervention / Treatment:
BEHAVIORAL: Project Connect Online, BEHAVIORAL: PCO PLUS
| Inclusion Criteria:
* women at least 18 years of age;
* first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
* ability to complete the intervention and assessments in English; and
* willingness to attend in-person PCO workshop;
Exclusion Criteria:
* male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
* local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
* use of a personal website to post cancer-relevant material in the past six months | 2,052 |
Study Objectives
While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.
Conditions: Cancer, Leukemia
Intervention / Treatment:
OTHER: Survey
| Inclusion Criteria:
* Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
* Female
* 18 years of age or older
* At least one reported live birth after childhood cancer diagnosis and treatment.
Exclusion Criteria:
* Unable to read and write.
* Unable to read and understand English. | 34,682 |
Study Objectives
Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors
Conditions: Non-melanoma Skin Cancer
Intervention / Treatment:
DEVICE: optical coherence tomography, in vivo reflectance confocal microscopy, 3D total body photography
| Inclusion Criteria:
* Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions
Exclusion Criteria:
* Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision
* Patients younger than 18 years
* Patients that are incapable of giving consent | 8,165 |
Study Objectives
This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.
Conditions: Rectal Adenocarcinoma, Recurrent Rectal Carcinoma, Stage IV Rectal Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7
Intervention / Treatment:
OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
| Inclusion Criteria:
* Histological or cytological confirmation of locally recurrent or metastatic rectal adenocarcinoma
* Note: Patients with locally recurrent/persistent disease within the pelvis after primary therapy (chemotherapy, surgery, and/or radiotherapy) are eligible
* Note: Patients who have had prior pelvic radiotherapy with a total dose of =< 54 Gy are eligible
* Note: Patients with or without metastatic disease (excluding untreated central nervous system \[CNS\] metastasis), with primary pelvic disease or pelvic recurrence are eligible
* Note: Patients with pelvic disease that is potentially resectable or unresectable are eligible
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Expected life expectancy >= 12 weeks
* Obtained =< 14 days prior to registration: Absolute neutrophil count (ANC) >= 1500/mm\^3
* Obtained =< 14 days prior to registration: Platelet count >= 100,000/mm\^3
* Obtained =< 14 days prior to registration: Hemoglobin >= 9.0 g/dL
* Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) (in patients with well-documented Gilbert's syndrome and the total bilirubin is grade 1, then direct bilirubin value must be =< 1.0 mg/dL)
* Obtained =< 14 days prior to registration: Aspartate transaminase (AST) =< 2 x ULN (=< 5 x ULN for patients with liver involvement)
* Obtained =< 14 days prior to registration: Alanine aminotransferase (ALT) =< 2 x ULN (=< 5 x ULN for patients with liver involvement)
* Obtained =< 14 days prior to registration: Alkaline phosphatase =< 3 x ULN
* Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN OR
* Obtained =< 14 days prior to registration: Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft-Gault formula
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; Note: patients must agree to adequate birth control during the study and for up to 6 months after discontinuation of study medication
* Patients must be able to take medications orally (i.e. no feeding tube)
* Provide written informed consent
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
* Able to complete questionnaires by themselves or with assistance
Exclusion Criteria:
* Primary resectable rectal cancer
* Prior treatment with TAS-102
* Chemotherapy or immunotherapy =< 28 days prior to registration
* Radiation therapy =< 28 days prior to registration; Note: patients with prior pelvic radiation therapy > 54 Gy are ineligible
* Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
* Other concurrent chemotherapy, immunotherapy, or any ancillary antitumor therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
* Untreated CNS or leptomeningeal metastasis
* Note: CNS or leptomeningeal disease must be stable for >= 3 months prior to registration
* History of seizure disorder
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks prior to registration
* Intestinal obstruction, uncontrolled gastrointestinal hemorrhage, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C
* Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy
* History of myocardial infarction =< 12 months prior to registration, severe/unstable angina, systematic congestive heart failure (CHF) New York Heart Association classification III or IV or CHF requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Major surgery =< 4 weeks prior to registration (the surgical incision should be fully healed prior to drug administration or radiation therapy)
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception | 12,513 |
Study Objectives
Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RAS/BRAF-mutant and TP53 wild-type CRC models. In vitro, in RKO cell lines (poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition), the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index. In vivo, in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93% decreases in tumor volume.
This trial is to conduct a single-center, Phase 1 dose escalation study of trametinib combined with HDM201 (a HDM2 inhibitor) in patients with advanced/metastatic RAS/RAF mutant and TP53 wt CRC.
Conditions: Colorectal Cancer, Advanced Cancer, Metastatic Cancer
Intervention / Treatment:
DRUG: HDM201, DRUG: Trametinib
| Inclusion Criteria:
* I1.Adult men and women ≥ 18 years at time of inform consent form signature.
* I2. Patients with histologically confirmed locally advanced or metastatic CRC bearing RAS (may be KRAS or NRAS or HRAS) or BRAF mutation, and TP53 wild type Note : TP53 wt status has to be determined by NGS sequencing of the full coding sequence using a tumor sample collected no longer than 36 months before inclusion.
Note: BRAF translocation are eligible.
* I3. Previously treated by at least one prior chemotherapy line of treatment in the advanced/metastatic setting.
* I4. Documented progressive disease and presence of at least one measurable lesion according to RECIST 1.1 based on screening tumor assessment.
* I5.Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* I6. Adequate organ function defined according to the following lab tests performed within 7 days before C1D1:
Bone marrow (without transfusion within 7 days) :Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Hemoglobin ≥ 9 g/ dL, Platelet count ≥ 100 x 109/L.
Coagulation: INR ≤ 1.5, aPTT ≤ 1.5 ULN. Note: patients receiving therapeutic anticoagulation should be on a stable dose for at least 7 days prior to C1D1.
Liver function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤3 ULN (or ≤ 5.0 ULN in case of liver metastasis or hepatic infiltration), Serum bilirubin ≤ 1.5 ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 ULN is acceptable). Renal function:
Calculated creatinine clearance ≥ 50 mL/ min/1.73m2 or serum creatinine ≤1.5ULN. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), formulae will be used for creatinine clearance calculation. Proteinuria ≤ +1 on dipstick or ≤ 1 g/24 hours.
* I7.Adequate cardiovascular function QTcF ≤470ms, Resting blood pressure systolic <160mmHg and diastolic<100mmHg, LVEF ≥50% as determined by transthoracic echocardiogram.
* I8.Presence of at least one biopsable lesion i.e. at least one lesion with a diameter ≥10 mm, visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permit core needle biopsy without unacceptable risk and suitable for retrieval of a minimum of three, but ideally four, cores using a biopsy needle of at least 16-gauge.
Note: RECIST target lesion are not to be biopsied.
*I9 Minimal wash out period required for prior treatments (delay from the last dose of the prior treatments to C1D1) : Any investigational drug > 28 days or five half-lives, whichever is longer, Major surgery >21 days, Note: If a patient underwent a major surgical procedure, he/she must have adequately recovered from the toxicity (i.e. wound healing) and/or complications from the intervention prior to starting therapy.
Radiotherapy > 28 days, Immunotherapy > 21 days, Chemotherapy > 14 days, Live vaccines > 28 days. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Growth factors targeting the myeloid lineage (e.g. GCSF, GM-CSF, M-CSF) > 14 days.
* I10 Patients able to swallow orally administered medication and do not have any clinically significant gastrointestinal abnormalities that may alter absorption of study drugs such as malabsorption syndrome or major resection of the stomach or bowels.
* I11 Fertile men must agree to use effective contraception from C1D1 until 4 months after the last dose of study drugs.
* I12 Women of child-bearing potential must have a negative serum pregnancy test within 7 days of first dose of study drugs and agree to use effective contraception from the date of negative pregnancy test to up to 4 months after the last dose of study drugs.
* I13 Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* I14 Patients must be covered by a medical insurance.
Exclusion Criteria:
* E1 Cancer disease considered curable with surgery or radiotherapy.
* E2 Prior exposure to HDM2 inhibitors and/or MEK inhibitors.
* E3 Presence of persisting AE related to anticancer treatments and Grade ≥ 2 according to CTCAE V5.0 except alopecia, neuropathy and biological values defined in inclusion criteria.
* E4 Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection that requires nutritional support).
* E5 Patients with significant active or uncontrolled cardiovascular disease or prior medical cardiac function disorders including for example uncontrolled hypertension, peripheral vascular disease, congestive heart failure (Class III-IV according to New York Heart Association \[NYHA\] scale), cardiac arrhythmia, or acute coronary syndrome within 6 months of C1D1 or myocardial infarction, angina pectoris, symptomatic pericarditis, within 12 months of C1D1 and patients with drug eluting stents for cardiovascular purposes.
* E6 .Patients diagnosed with treatment-related interstitial lung disease or pneumonitis.
* E7 Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include :basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of disease for ≥ 2 years.
* E8 Patients requiring the use of the following forbidden concomitant treatments :
Any anticancer therapy other than the protocol specified therapies including any investigational agent, any chemotherapy, radiotherapy (except palliative radiotherapy after discussion with the sponsor), immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
Strong and moderate inducers and inhibitors of CYP3A4/5, Live vaccines, CYP3A4/5 substrates with a narrow therapeutic index: prohibited 24 hours prior and 1 week after HDM201 administration, Substrates of OATP1B1: prohibited 24 hours prior and 48 hours after HDM201 administration.
* E9 History or current evidence of Retinal Vein Occlusion (RVO) or central serous retinopathy (CSR) or risk factors including uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes.
* E10 Patients with active hemolysis.
* E11 Known VIH infection
* E12 Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* E13 Symptomatic CNS metastases. Note: Patients with CNS metastases are eligible only if they are asymptomatic, off corticosteroids, radiographically stable for at least 2 months prior C1D1 and considered not to be at risk of bleeding.
* E14 Hypersensitivity to trametinib or HDM201 or any of their excipients.
* E15 Pregnant or breast-feeding female patients. | 26,889 |
Study Objectives
Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.
Conditions: Prostate Cancer
Intervention / Treatment:
RADIATION: Hypofractionated Radiosurgery
| Inclusion Criteria:
* Localised, histopathologically confirmed Prostate Cancer (cT1-3 N0 M0)
* Gleason-grade ≤7
* Guideline-based staging
* Age ≥ 60 years
* PSA < 15 ng/ml
* Volume of the prostate <80 cm³
* IPSS-Score ≤12
* Written informed consent
Exclusion Criteria:
* History of prior pelvic radiotherapy
* Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
* Immunosuppressive therapy
* Relevant comorbidity thought to adversely affect treatment compliance,
* Legal incapacity or lack of informed consent | 34,683 |
Study Objectives
This is a phase I clinical trial examining the safety, feasibility, and toxicity of gemcitabine and erlotinib when given in combination with capecitabine in adult patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma.
Treatment will be administered at Moffitt on an outpatient basis and consists gemcitabine once per week for 3 weeks, followed by a week off treatment. Erlotinib (tablet) taken by mouth continuously starting with day one of cycle 1 with capecitabine taken twice per day on days 1-14 of each cycle followed by a 2 week off treatment rest period. An accelerated dose-escalation scheme will be employed with 4 planned dose levels. Whenever patients have been enrolled at a given dose with at most 1 DLT, the protocol will be stopped and the dose will be called the maximum tolerated dose (MTD). Patients will be treated at the recommended phase II dose (RPTD) to confirm tolerability at that dose.
In the absence of treatment delays due to adverse events, treatment may continue for 6 cycles or until disease progression and patients may continue on the study regimen unless they experience an adverse event that meets the criteria for a dose limiting toxicity.
Conditions: Metastatic Pancreatic Carcinoma
Intervention / Treatment:
DRUG: gemcitabine, DRUG: capecitabine, DRUG: erlotinib
| Inclusion Criteria:
* Histologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable.
* Previously untreated with chemotherapy in the metastatic setting. Prior 5-fluorouracil (5-FU) or capecitabine treatment is allowed if: 1) it was given as part of a combined modality chemoradiation regimen and 2) no greater than 30% of bone marrow was included in the field and 3) the treatment free interval has been > 6 weeks
* Must have measurable disease, defined as at least one lesion that can be measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
* Age greater than or equal to 18 years
* Because no dosing or adverse event data are currently available on the use of capecitabine in combination with gemcitabine and erlotinib in patients <18 years of age, children are excluded from this study. Pancreatic adenocarcinoma is primarily a disease of the elderly.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2 (Karnofsky greater than or equal to 60%).
* Life expectancy > 8 weeks
* Must have normal organ and marrow function as defined below:
1. leukocytes, greater than or equal to 3,000/μl
2. absolute neutrophil count, greater than or equal to 1,500/μl
3. platelets, greater than or equal to100,000/μl
4. total bilirubin, less than or equal to 2.5 X institutional upper limit of normal
5. AST(SGOT)/ALT(SGPT), less than or equal to 2.5 X institutional upper limit of normal (ULN)
6. AST(SGOT)/ALT(SGPT), less than or equal to 5 X institutional ULN in patients with liver metastasis
7. creatinine, less than or equal to 1.5 X institutional ULN
8. creatinine clearance, > 30 ml/min (Cockcroft-Gault method)
* Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
* Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior chemotherapy for pancreatic adenocarcinoma in the metastatic setting are not eligible.
* Chemoradiation within the last 6 weeks prior to registration are not eligible
* Known allergy or severe reactions to gemcitabine, capecitabine, or tyrosine kinase inhibitors are not eligible
* May not be receiving any other investigational agents or received investigational agents within the 28 days prior to registration.
* Known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
* Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell, or in-situ cervical cancer
* ECOG PS 3-4
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because gemcitabine and capecitabine are Class D agents with the potential for teratogenic or abortifacient effects.
* Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib or other agents administered during the study.
* Creatinine clearance < 30 ml/min (Cockcroft-Gault method)
* Patients that require ongoing (chronic) treatment with medications metabolized by CYP3A4 (saquinavir, ritonavir, nelfinavir, indinavir, ketoconazole, itraconazole, nefazodone, clarithromycin, atazanavir, rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, St. John's Wort) who cannot be switched to alternate medications that are not metabolized by CYP3A4 are excluded. | 8,146 |
Study Objectives
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
Conditions: Lymphoma
Intervention / Treatment:
DRUG: Fludarabine Phosphate (Fludara)
| Inclusion Criteria:
* Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
* Patients with measurable lesions (major axis > 1.5 cm by CT)
* Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
* Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
* Patients who have PS Grade 0 to 2 in the criteria of ECOG
* Patients with adequately maintained organ functions
Exclusion Criteria:
* Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
* Patients who are positive for HBs antigen, HCV antibody or HIV antibody
* Patients who received G-CSF or blood transfusion within 1 week before the screening test
* Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
* Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception | 31,828 |
Study Objectives
* Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal cancers (CRCs).
* Literature data show that this unique tumor population appears to be poorly responsive to conventional chemotherapy and conversely reveals excellent results to immunotherapy.
* Our data, as demonstrated by propensity score-matched and win ratio analysis, show that there are no substantial differences between MSI and MSS tumors in early CRC stages treated with surgery alone.
* On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC stages undergoing conventional adjuvant treatment.
* Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to optimize treatment.
Conditions: MSI-H Colorectal Cancer
Intervention / Treatment:
PROCEDURE: colorectal resection
| Inclusion Criteria:
* all consecutive CRC patients observed from January 2014 to December 2021
Exclusion Criteria:
* Patients with suspected or confirmed Lynch's syndrome (12 patients) and rectal cancers (98 patients) undergoing neoadjuvant treatment | 5,168 |
Study Objectives
To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
Conditions: MPN (Myeloproliferative Neoplasms)
Intervention / Treatment:
DRUG: Ruxolitinib
| Inclusion Criteria:
* Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
* Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
* INR <= 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
* Hemoglobin level at least 6.5 g/dL at Screening visit
* Willingness to be transfused to treat low hemoglobin levels
Exclusion Criteria:
* Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
* Males who cannot comply with birth control use to avoid fathering a child
* Platelet count < 50 x10\^9/L or absolute neutrophil count (ANC) < 1 x10\^9/L at the Screening visit
* Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be > 1.5 x upper limit of normal at study entry. | 7,178 |
Study Objectives
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with bevacizumab and to see how well they work in treating patients with unresectable or metastatic kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving vorinostat together with bevacizumab may kill more tumor cells.
Conditions: Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
Intervention / Treatment:
DRUG: vorinostat, DRUG: bevacizumab
| Inclusion Criteria:
* No known CNS metastasis
* ECOG performance status 0-2
* Life expectancy > 6 months
* LVEF ≥ 45%
* Absolute neutrophil count ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST/ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
* PT/INR ≤ 1.5
* Urine protein < 1+ by urinalysis OR < 1 g by 24-hour urine collection
* Not pregnant
* No nursing during and for 6 months after completion of study treatment
* Negative pregnancy test
* Fertile patients must use effective contraception for 2 weeks prior, during, and for 6 months after completion of study treatment
* No other currently active malignancy defined as > 30% risk of relapse upon completion of anticancer therapy, except nonmelanoma skin cancer
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA)
* No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No evidence of bleeding diathesis or coagulopathy
* No active bleeding or pathological conditions that carry high risk of bleeding (i.e., tumor involving major vessels or known varices)
* No ongoing, active infection
* No New York Heart Association class II-IV congestive heart failure
* No angina pectoris requiring nitrate therapy
* No cardiac arrhythmia
* No myocardial infarction within the past 6 months
* No history of cerebrovascular accident within the past 6 months
* No uncontrolled hypertension (defined as systolic blood pressure (BP) > 160 mm Hg and/or diastolic BP > 90 mm Hg on medication)
* No history of peripheral vascular disease
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No serious nonhealing wound, ulcer, or bone fracture
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No significant traumatic injury in the past 28 days
* At least 4 weeks since prior major surgery or open biopsy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* More than 4 weeks since prior radiotherapy
* At least 2 weeks since prior tyrosine kinase inhibitor
* Prior palliative radiotherapy to metastatic lesions allowed provided ≥ 1 measurable and/or evaluable lesion has not been irradiated
* No more than 2 prior systemic treatments for metastatic disease, including immunotherapy, receptor tyrosine kinase inhibitor therapy, chemotherapy, or investigational therapy
* No prior therapy with bevacizumab, vascular endothelial growth factor-trap, or histone deacetylase inhibitors, including valproic acid
* No core biopsy within 1 week prior to day 1 of study treatment
* No planned major surgery during study treatment
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* Concurrent stable-dose prophylactic anticoagulation (i.e., warfarin or low molecular weight heparin) allowed provided requirements for INR are met
* Histologically confirmed renal cell carcinoma, clear cell component, unresectable or metastatic disease (patients with a primary tumor in place who are eligible for surgery are strongly encouraged to undergo a nephrectomy prior to study entry to increase potential survival)
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm with spiral CT scan
* The following histologies are not allowed:
* Papillary, sarcomatoid carcinoma
* Chromophobe carcinoma
* Oncocytoma
* Collecting duct tumor
* Transitional cell carcinoma
* WBC ≥ 3,000/mm\^3 | 28,337 |
Study Objectives
The purpose of this study is:
* To examine if oral administration of Pariet (proton pump inhibitor, 20mg tablets, twice daily for 5 days) before Endoscopic mucosal resection(EMR) exhibits preventive effects of ulcer bleeding compared with placebo group (preoperative administration of placebo)
* To evaluate the effects on the suppression of acid secretion of preoperative administration of an Proton pump inhibitor
Conditions: Early Gastric Adenocarcinoma, Adenocarcinoma, Tubular
Intervention / Treatment:
DRUG: rabeprazole, DRUG: placebo
| Inclusion Criteria:
* Patients who have EMR planned as well as meet the criteria described below will be selected as study subjects
* Patients in whom EMR is indicated:
1. Gastric adenoma
2. Early gastric adenocarcinoma
* Moderately or well differentiated adenocarcinoma
* Gastric cancer limited to only mucosa on endoscopic ultrasonography
* No invasion of lymph nodes or metastases (diagnosed by CT)
3. EMR to be performed for other diagnostic purposes
* Women of child-bearing potential should avoid pregnancy
* Subjects who consented to a EMR procedure in writing
Exclusion Criteria:
* Patients who meet the criteria described below should be excluded from study subjects:
1. Younger than 18 years old
2. Patients with a history of upper gastrointestinal surgery or vagotomy
3. Patients with serious adverse reactions secondary to cardiac, renal, hepatic, or hematologic diseases (e.g. creatinine> 2.5 mg/dl, total bilirubin >3.0 mg/dl)
4. Patients with diseases that may have a great impact on the clinical study
5. Patients to whom the stimulation of gastrointestinal movement poses risks as in gastrointestinal bleeding, mechanical ileus and perforation
6. Women who are pregnant or nursing
7. Patients who are being treated with adrenocorticoid steroids, nonsteroidal anti-inflammatory drugs including aspirin, or other ulcer inducers
8. Patients who are taking other antiulcer drugs (antacids, antihistamines, etc) that may affect the efficacy assessments of the study drug (but, except for patients not taking the drugs over 7 days)
9. Patients with severe psychiatric diseases
10. Patients who received other investigational drugs within 30 days prior to the start of this study or who are currently participating in other clinical study
11. Patients who did not consent to the clinical study
12. Patients who can not be examined
* Patients with bleeding tendency
* Patients with esophageal varices
* Patients with esophageal ulcer, stricture, or obstruction
* Patients who have pacemaker or implantable cardiac defibrillator in place | 36,165 |
Study Objectives
The investigators propose to compare the effects of a 12-week, supervised, site-based group yoga intervention on cognitive function, functional fitness, and well-being in middle-aged cancer survivors. Subjects will be randomly assigned to one of three exercise conditions: a yoga group, an aerobic walking group or a strength training group. All sessions (2-3 times per week) will be led by a trained exercise leader for a total of 150 minutes of exercise each week for the 12-week intervention.
Conditions: Cancer, Cancer-related Problem/Condition, Exercise
Intervention / Treatment:
BEHAVIORAL: Yoga, BEHAVIORAL: Stretching and Toning, BEHAVIORAL: Aerobic Walking
| Inclusion Criteria:
* 30-70 years of age
* Cancer diagnosis
* 1 year since last cancer treatment (surgery, chemotherapy, and/or radiation)
* Not planning to receive treatment during study period
* Completion of Physical Activity Readiness Questionnaire (PAR-Q)
* Ambulatory and absence of health conditions that may be exacerbated by yoga, walking, or strength training
* Physician consent (if deemed necessary)
* Low-active, i.e. less than 150 minutes/week of moderate to vigorous exercise, no current yoga practice (including within last six months)
* Intention to remain in the Champaign-Urbana area over the study duration
* Willingness to be randomly assigned to one of the three groups (yoga, aerobic walking, strength training)
* Comfortable with reading, writing, and speaking English
Exclusion Criteria:
* Below 30 or above 70 years of age
* Cancer diagnosis of the brain
* Less than 1 year since last treatment (surgery, chemotherapy, and/or radiation) or plans to receive treatment during study
* Determined ambulatory or 'high risk' based on responses to PAR-Q
* High-active (exercising more than 150 minutes/week in the last six months)
* No consent from physician
* Intent to be away from the Champaign-Urbana area for an extended period of time during the study
* Inability to communicate effectively in English | 15,869 |
Study Objectives
Project 5 of the Texas HCC Consortium (THCCC) is a comparative effectiveness pragmatic randomized control trial (RCT) of outreach strategies to increase hepatocellular cancer (HCC) surveillance process completion among a socioeconomically and racially diverse cohort of Texans with cirrhosis. Through this project the investigators will implement and evaluate system-level mailed outreach interventions to identity at-risk patients with cirrhosis, promote HCC surveillance, and ensure timely follow-up of tests at UT Southwestern (UTSW) Medical Center, Parkland Health and Hospital System (PHHS), and the Houston Veterans Affairs (VA) Medical Center. The study population will include adult patients with documented or unrecognized cirrhosis and at least one outpatient clinic visit in year prior to randomization. Patients will be identified using an EMR-enabled case identification algorithm. The investigators will randomize 3000 patients (1500 per arm) identified by this algorithm to: usual care, with opportunistic visit-based HCC surveillance (Group 1); or, mailed HCC surveillance outreach with patient education and patient navigation services (Group 2).
Conditions: Carcinoma, Hepatocellular, Liver Neoplasms
Intervention / Treatment:
BEHAVIORAL: Outreach with patient education and patient navigation services
| Inclusion Criteria:
* Adult patients (>21 years old)
* Documented cirrhosis
* Unrecognized cirrhosis
* An outpatient visit in year prior to randomization
* English or Spanish speaking
Exclusion Criteria:
* History of HCC
* History of liver transplantation
* Child Pugh C cirrhosis
* Significant comorbid conditions with life expectancy < 1 year, (e.g., extrahepatic malignancy) | 24,141 |
Study Objectives
This randomized phase I/II trial studies the side effects and best dose of lapatinib ditosylate and to see how well it works in treating patients with ductal breast carcinoma in situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Ductal Breast Carcinoma In Situ, HER2/Neu Positive
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DRUG: Lapatinib Ditosylate, OTHER: Placebo
| Inclusion Criteria:
* Participants must be premenopausal or postmenopausal
* Participants must have a diagnosis of ductal carcinoma in situ made by core needle biopsy
* The DCIS cells must have high expression of human epidermal growth factor receptor 2 (erbB2) (3+ by immunohistochemical staining or amplification by fluorescence in situ hybridization \[FISH\]), and/or have detectable expression of epidermal growth factor receptor (EGFR) (1+ or more by immunohistochemical staining)
* All participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* Individuals with a diagnosis of breast cancer, non-melanoma skin cancer, cervical cancer in situ, or early bladder cancer are eligible if they have not been treated with chemotherapy, biological therapy, or breast radiotherapy to the breast currently affected by DCIS within one year; in addition, individuals with a diagnosis of breast cancer may not have used tamoxifen, raloxifene, or other antiestrogen compounds within three months of study day 1
* If subjects are of reproductive potential, they must agree to use a reliable contraceptive method or be sexually abstinent; subjects must fulfill these conditions beginning at the time of starting study medications and ending one month after study termination
* Negative serum pregnancy test (beta-human chorionic gonadotropin \[HCG\]) at baseline (within 30 days of day 0) for women of child bearing potential
* Serum creatinine =< 1.5 times the institution?s upper limit of normal
* Total bilirubin =< 1.5 times the institution's upper limits of normal
* Serum glutamic oxaloacetic transaminase (SGOT) =< 1.5 times the institution's upper limits of normal
* Alkaline phosphatase =< 1.5 times the institution's upper limits of normal
* Albumin =< 1.5 times the institution's upper limits of normal
* White blood cells (WBC) > 4.0 k/uL
* Platelet count > 100,000/uL
* Hematocrit of > 30%
* Cardiac ejection fraction within normal limits for the institution by multi gated acquisition scan (MUGA) scan or normal cardiac ultrasound (defined as within the upper limit of normal \[ULN\] for the institution)
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* Willingness to refrain from donating blood to others during the study
Exclusion Criteria:
* Individuals are ineligible if they have either active cancer or a prior history of malignancies other than (e.g., breast cancer, skin cancer \[basal or squamous cell carcinoma\], cervical cancer in situ, or early bladder cancer \[preinvasive transitional cell carcinoma of the bladder\]) within the past five years
* Participants are ineligible if they are currently being treated with tamoxifen, raloxifene, or with aromatase inhibitors (letrozole, anastrozole, exemestane)
* Individuals are ineligible if they have received chemotherapy, biological therapy (e.g., Herceptin), or radiotherapy for the treatment of any cancer within 1 year or if they have received tamoxifen, raloxifene, letrozole, anastrozole, or exemestane therapy within 3 months of study day 1
* Individuals currently receiving anticoagulation therapy (e.g., Coumadin) are ineligible
* Blood urea nitrogen \[BUN\] > 1.5 x ULN or
* Creatinine \[Cr\] > 1.5 x ULN
* SGOT > 1.5 x ULN
* Serum glutamate pyruvate transaminase (SGPT) > 1.5 x ULN
* Alkaline phosphatase > 1.5 x ULN
* Bilirubin > 1.5x ULN
* Individuals who are currently participating in a study of an investigational drug
* Pregnancy, lactation or unwillingness to use a reliable contraceptive method in women of childbearing potential
* Severe underlying chronic illness or disease, such as uncontrolled diabetes
* Individuals with known congestive heart disease or previous myocardial infarction are ineligible
* Patients taking any prohibited medications
* Individuals with hypokalemia or hypomagnesemia are ineligible unless these conditions are corrected to within normal limits before starting drug
* Individuals with congenital long QT syndrome or baseline QTcF intervals > 480 msec on electrocardiogram (EKG)
* Individuals taking anti-arrhythmics, beta blockers, or other medications that may lead to QT prolongation
* Individuals who have received a cumulative dose of anthracycline therapy greater than 500 mg/m\^2 are ineligible | 23,260 |
Study Objectives
This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard.
Conditions: Malignant Neoplasm of Breast, Breast Cancer
Intervention / Treatment:
DRUG: Genomically Directed Monotherapy, OTHER: Observation/Standard Therapy
| Inclusion Criteria:
*Written informed consent and HIPAA authorization for release of personal health information.
NOTE: HIPAA authorization may be included in the informed consent or may be obtained separately.
NOTE: Central pathology review may be conducted any time after definitive surgery. Consenting participants may be pre-registered to the study and proceed with central pathology review before full eligibility has been confirmed. However, ALL of the eligibility criteria must be met and formal study registration completed prior to submission of the sample for sequencing.
* Age ≥ 18 years at the time of consent.
* ECOG Performance Status 0 or 1 within 14 days prior to study registration.
* Women and men of childbearing potential must be willing to use an effective method of contraception (e.g. hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after protocol therapy discontinuation.
* Women of childbearing potential must have a negative pregnancy test within 30 days prior to study registration. Women should be counseled regarding acceptable birth control methods to utilize from the time of screening to start of treatment. If prior to treatment after discussion with the subject it is felt by the treating physician there is a possibility the subject is pregnant a pregnancy test should be repeated.
NOTE: Women are considered not of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or they are postmenopausal for at least 12 consecutive months.
* Women must not be breastfeeding.
* Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, clinical stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by physical examination and/or breast imaging prior to study registration. NOTE: ER, PR and HER2 status will be confirmed by central pathology review prior to randomization. ER and PR will be considered negative if ≤ 1% of cells stain weakly positive. HER2 will be considered negative if scored 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of < 2.0 or < 6 copies per cell.
* Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Participants who received preoperative therapy as part of a clinical trial may enroll. Participants may not have received adjuvant chemotherapy after surgery prior to randomization. Bisphosphonate use is allowed.
* Must have completed definitive resection of primary tumor. The most recent surgery for breast cancer must have been completed at least 14 days prior (but no more than 84 days prior) to study registration. NOTE: Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however participants with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy. Participants with margins positive for lobular carcinoma in situ (LCIS) are eligible. Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable.
* Must have significant residual invasive disease at the time of definitive surgery following preoperative chemotherapy. Significant residual disease is defined as at least one of the following:
* Residual Cancer Burden (RBC) classification II or III\^6
* Residual invasive disease in the breast measuring at least 2 cm. The presence of DCIS without invasion does not qualify as residual disease in the breast.
* Residual invasive disease in the breast measuring at least 1cm with any lymph node involvement (does not include metastases in lymph node which are only detected by immunohistochemistry).
* Any lymph node involvement that results in 20% cellularity or greater regardless of primary tumor site involvement (includes no residual disease in the breast).
* Must have an FFPE tumor block with tumor cellularity of 20% or greater. NOTE: Prior to randomization, the tumor cellularity will be confirmed by central pathology review and percent values will be double checked at Paradigm (a Next Generation Sequencing Company).
* BREAST RADIOTHERAPY:
* Whole breast radiotherapy is required for participants who underwent breast-conserving therapy, including lumpectomy or partial mastectomy. Participants must have completed radiotherapy at least 14 days prior (but no more than 84 days prior) to study registration.
* Participants with a primary tumor > 5 cm or involvement of ≥4 lymph nodes who require a mastectomy must also have radiotherapy pre- or post-operatively at the discretion of the treating physician. For participants with primary tumors ≤ 5 cm or with < 4 involved lymph nodes, provision of post-mastectomy radiotherapy is at the discretion of the treating physician. Registration must occur within 84 days of the completion of the last local therapy.
* For radiation required prior to surgery, the participant must register within 84 days of surgery. Also, participants in this situation would not be required to have additional post-mastectomy radiation therapy.
* For those participants who do not require radiation, registration must be within 84 days of surgery.
* No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease.
* No treatment with any investigational agent within 30 days prior to study registration.
* No history of chronic hepatitis B or untreated hepatitis C.
* Adequate laboratory values must be obtained within 14 days prior to study registration.
* Hemoglobin (Hgb) >= 9.0 g/dL
* Platelets >= 100 K/mm\^3
* Absolute neutrophile count (ANC) >= 1.5 K/mm\^3
* Calculated creatinine clearance of >= 50 cc/min using the Cockcroft-Gault formula:
* Males: (140-Age in years) x Actual body weight in kg / 72 x Serum creatinine (mg/dL)
* Females: Estimated creatinine clearaNCE FOR MALES X 0.85
* Bilirubin <= 1.5 x ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin <= 3.0 mg/dL)
* Aspartate aminotransferase (AST, SGOT) <= 2.5 x ULN
* Alanine aminotransferase (ALT, SGPT) <= 2.5 x ULN
* Left ventricular ejection fraction within normal limits obtained within 30 days prior to study registration.
NOTE: Participants with an unstable angina or myocardial infarction within 12 months of study registration are excluded.
* No clinically significant infections as judged by the treating physician.
* Must consent to allow submission of adequate archived tumor tissue sample from definitive surgery for genomic assessment of tumor.
* Must consent to collection of whole blood samples for genomic analysis
* No clinically significant arrhythmia or baseline ECG abnormalities in the opinion of the treating physician.
Exclusion Criteria:
* No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease.
* No treatment with any investigational agent within 30 days prior to study registration.
* No history of chronic hepatitis B or or untreated hepatitis C.
* No clinically significant infections as judged by the treating physician.
* No active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer found on cystectomy): Active second malignancy is defined as a current need for cancer therapy or a high possibility (> 30%) of recurrence during the study. Previous contralateral breast cancer is allowable unless it meets "active" criteria as stated above. | 22,053 |
Study Objectives
The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.
Conditions: Small-cell Lung Cancer
Intervention / Treatment:
DRUG: Berzosertib, DRUG: Berzosertib, DRUG: Topotecan
| Inclusion Criteria:
* Dose level 1 participants with histologically proven advanced solid tumors, for which no effective standard therapy exists, or standard therapy has failed or cannot be tolerated
* Dose level 1 participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) less than or equal to (<=) 1 and Karnofsky Scale greater than or equal to (>=) 70 percent (%)
* Dose level 2 and main part participants with ECOG PS <= 2 and Karnofsky Scale >= 60%
* Dose level 2 and main part participants with histologically confirmed SCLC
* Dose level 2 and main part participants with radiologically confirmed progression after first-line or chemoradiation platinum-based treatment (carboplatin or cisplatin), with or without immunotherapy, for treatment of limited or extensive stage SCLC, with a Platinum-free interval (PFI) less than (<) 90 days. The PFI is measured by the elapsed time from the last day of the regimen of a platinum-based treatment until the first day of documented disease progression
* Dose level 2 and main part participants with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECISTv1.1) at Screening. Evidence of measurable disease must be confirmed by the IRC prior to start of treatment
* Tumor tissue provision: archival (collected within 12 months before date of informed consent form \[ICF\]) signature for Screening) or fresh biopsy specimen, if medically feasible
* Have adequate hematologic and renal function
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Clinically relevant (that is \[i.e.\], active), uncontrolled intercurrent illness including, but not limited to, severe active infection including, severe acute respiratory syndrome coronavirus-2 infection/coronavirus disease 2019, immune deficiencies, uncontrolled diabetes, uncontrolled arterial hypertension, symptomatic congestive heart failure (New York Heart Association Classification greater than or equal to \[>=\] Class III), unstable angina pectoris, myocardial infarction, uncontrolled cardiac arrhythmia, cerebral vascular accident/stroke. Calculated corrected QT interval (QTc) average (using the Fridericia correction calculation) of greater than \[>\] 450 millisecond (msec) for males and > 470 msec for females. Any psychiatric illness/social situations that would limit compliance with study requirements
* Unstable brain metastases; however, participants with known brain metastases may be enrolled in this clinical study if they are clinically stable (without evidence of progression by imaging for at least 2 weeks prior to the first study intervention dose and any neurologic symptoms have returned to baseline), have no evidence of new brain metastases, and are on a stable or decreasing dose of steroids for at least 14 days prior to study intervention Participants with carcinomatous meningitis are excluded regardless of clinical stability. Screening central nervous system imaging is not mandatory
* Prior malignant disease within the last 3 years. Exceptions include fully resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ cervical cancer, fully resected ductal carcinoma in situ of the breast, superficial or noninvasive bladder cancer, and Stage IA, Grade I endometrioid endometrial cancer with no myometrial invasion, that has undergone curative therapy. Participants with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor
* Participants not recovered from adverse events (AEs) Grade > 1 from prior anticancer therapies, including surgeries. Exception: Grade 2 AEs not constituting a safety risk (for example \[e.g.\], alopecia), based on the Investigator's judgment; must consult with the medical Monitor prior to enrollment.
* Other protocol defined exclusion criteria could apply | 27,431 |
Study Objectives
Retrospective chart review Study of patients with BRAF V600 positive advanced (unresectable or metastatic) melanoma, who were treated with targeted therapy in routine clinical practice in Russian Federation
Conditions: Cutaneous Melanoma, Stage IV, BRAF V600 Mutation
Intervention / Treatment:
| Inclusion Criteria:
* Histological confirmed cutaneous melanoma
* BRAF V600 mutation
* Treated by at least one therapy line including BRAFi / MEKi
Exclusion Criteria:
* No data of targeted therapy usage and treatment outcomes (data of evaluation of effect and data of objective examination) | 37,517 |
Study Objectives
The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: cholecalciferol, OTHER: placebo
| Inclusion Criteria:
* Diagnosis of prostate cancer (by prostate biopsy)
* Scheduled to undergo a prostatectomy
* Ability to give his own consent to participate in the study
Exclusion Criteria:
* Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
* Vitamin D3 supplementation greater than or equal to 1000 IU daily | 23,931 |
Study Objectives
Bone is the most common site of spread of breast cancer and bone metastases will occur in roughly 70% of women with advanced disease. These patients are at risk of developing bone complications that cause significant impact on both patient morbidity and mortality. Close to two-thirds of women with bone metastases will go on to develop at least one of these complications, termed a skeletal related event (SRE), defined as 1) pathological fractures, 2) pain requiring radiation or surgical intervention, 3)spinal cord compression, and 4) hypercalcemia. In addition to SREs, most breast cancer patients with bone metastases have some degree of pain associated with their disease. Understandably these factors negatively impact their quality of life. Furthermore, the development of an SRE in this population has been shown to be associated with shorter overall survival. Prevention or delay in onset of these complications is therefore an important therapeutic goal.
Conditions: Metastatic Breast Cancer With Bone Involvement
Intervention / Treatment:
DRUG: Zoledronic acid
| Inclusion Criteria:
* Patients must have histologically confirmed breast cancer.* Radiological or pathological evidence of bone metastases. (positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic breast cancer).* Patient has not yet started on BP therapy for metastatic breast cancer to bone.* Renal (serum creatinine, BUN), hepatic (AST, ALT, Bilirubin) function within the institutional normal range as assessed within 1 month of study entry.* Age >= 18 years.* Karnofsky performance status ≥ 50.* Life expectancy > 6 months.* Ability to understand and the willingness to sign a written informed consent document.* Patients may receive any chemotherapy, biological or endocrine treatment considered appropriate by the treating physician. This can be changed during the course of the study as clinically indicated.* Patients may be on another clinical trial, if allowed by the Trial Steering Committee for that trial.* Patients are willing to take calcium and vitamin D supplements as recommended, while on study.
Exclusion Criteria:
* Hypersensitivity or known allergy to bisphosphonates.* Patient currently taking Bisphosphonate therapy for metastatic breast cancer to bone (Clodronate, Pamidronate, Zoledronic Acid, Ibandronate, Calcitonin). Bisphosphonates for the treatment of other bone disease (osteoporosis, osteopenia, Paget's disease, etc) but not Zoledronic Acid, are permitted.* Acute or chronic renal insufficiency.* Hypocalcemia as defined by serum calcium less than institutional normal range.* Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks), or presence of osteonecrosis of the jaw.* Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved).* Patients with baseline hypocalcemia.* Patients who have received ZA for prevention of breast cancer treatment-induced osteopenia or osteoporosis within the last 1 year.* History and/or electrocardiographic evidence of atrial fibrillation.* Pregnancy or lactation. | 2,476 |
Study Objectives
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
Conditions: Neoplasm Metastasis
Intervention / Treatment:
RADIATION: Novalis Shaped Beam Surgery
| Inclusion Criteria:
* Patients must have a previously histopathologically proven diagnosis of malignancy.
* Patients must be evaluated by Neurosurgery and Radiation Oncology
* Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-3.
* All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
* All lesions must be <4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
* In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of <5 cm.
* Patients must have a Karnofsky performance status ≥60.
* Extracranial disease must not be considered imminently life threatening (<2 month anticipated survival from extracranial disease).
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
* KPS<60
* life expectancy > 2 months | 37,658 |
Study Objectives
Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)
Conditions: Carcinomas of the Esophagogastric Junction
Intervention / Treatment:
PROCEDURE: Esophagogastrectomy
| Inclusion Criteria:
* Carcinoma of the esophagogastric junction (AEG type II)
* Age of Minimum 18 years
Exclusion Criteria:
* non | 24,149 |
Study Objectives
The purpose of this study is to determine the feasibility of implementing a randomized controlled study of the intervention (Geriatric Assessment followed by an integrated care plan carried out by the multidisciplinary geriatric oncology team) designed to maintain/improve quality of life and functional status in older adults with advanced gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.
Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer treatment decision of the cancer specialist.
Conditions: Breast Cancer, Gastrointestinal Cancer, Genitourinary Cancer
Intervention / Treatment:
PROCEDURE: GA and Integrated Care Plan
| Inclusion Criteria:
* Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or breast cancer
* Referred for first-line chemotherapy
* Ability to speak English
* Physician estimated life expectancy >6 months
* An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2
* Ability to provide informed consent
Exclusion Criteria:
* Previous chemotherapy for current stage of disease | 23,335 |
Study Objectives
This randomized phase II trial studies temozolomide, radiation therapy, and cediranib maleate to see how well they work compared with temozolomide, radiation therapy, and a placebo in treating patients with newly diagnosed glioblastoma (a type of brain tumor). Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether temozolomide and radiation therapy are more effective when given with or without cediranib maleate in treating glioblastoma.
Conditions: Adult Glioblastoma, Adult Gliosarcoma
Intervention / Treatment:
RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Cediranib Maleate, RADIATION: Intensity-Modulated Radiation Therapy, OTHER: Laboratory Biomarker Analysis, OTHER: Placebo Administration, DRUG: Temozolomide
| Inclusion Criteria:
* Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization \[WHO\] grade IV) confirmed by central review prior to step 2 registration
* Tumor tissue that is determined by central pathology review prior to step 2 registration to be of sufficient size for analysis of MGMT status
* Patients must have at least 1 block of tumor tissue; submission of 2 blocks is strongly encouraged
* Cavitron ultrasonic aspirator (CUSA)-derived material is not allowed; fresh frozen tumor tissue acquisition is encouraged
* Diagnosis must be made by surgical excision, either partial or complete; stereotactic biopsy is not allowed because it will not provide sufficient tissue for MGMT analysis
* The tumor tissue must be sent as soon as possible to maximize the likelihood of eligibility; tumor tissue may not be submitted later than 28 days after the surgical procedure, because tissue analysis will not be able to be performed in time for treatment to commence by the mandatory 6-week post-surgery outer limit; submission of tissue earlier than 28 days post-surgery is highly recommended
* The tumor must have a supratentorial component
* History/physical examination, including neurologic examination, within 14 days prior to step 2 registration
* The patient must have recovered from the effects of surgery, post-operative infection, and other complications before step 2 registration
* A diagnostic contrast-enhanced magnetic resonance imaging (MRI) of the brain must be performed preoperatively and postoperatively prior to step 1 registration; the postoperative scan must be performed within 28 days prior to step 1 registration
* Documentation of steroid doses/concurrent medications within 14 days prior to step 2 registration
* Karnofsky performance status >= 70 within 14 days prior to step 2 registration
* Complete blood count (CBC)/differential obtained within 14 days prior to step 2 registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) >= 1,800 cells/mm\^3
* Platelets >= 100,000 cells/mm\^3
* Hemoglobin >=10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable)
* Adequate renal function, as defined below:
* Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to step 2 registration
* Creatinine =< 1.7 mg/dl within 14 days prior to step 2 registration
* Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to step 2 registration
* Systolic blood pressure =< 140 mm Hg AND diastolic pressure =< 90 mm Hg within 14 days prior to step 2 registration in the presence or absence of a stable regimen of anti-hypertensive therapy
* Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 1 week of step 2 registration
* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \[LMW\] heparin) must meet both of the following criteria:
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* In-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
* Patient must provide study specific informed consent prior to step 1 registration
* Women of childbearing potential and male participants must practice adequate contraception
* For females of child-bearing potential, negative serum pregnancy test within 14 days prior to step 2 registration
Exclusion Criteria:
* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years; (for example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible)
* Recurrent or multifocal malignant gliomas
* Metastases detected below the tentorium or beyond the cranial vault
* Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable (except temozolomide or cediranib); prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted
* Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization
* Transmural myocardial infarction within the last 6 months
* Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 14 days of step 2 registration
* New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to step 2 registration
* History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
* Serious and inadequately controlled cardiac arrhythmia
* Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to step 2 registration, with the exception of the craniotomy for tumor resection
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 2 registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 2 registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
* Active connective tissue disorders, such as lupus or scleroderma, which in the opinion of the treating physician may put the patient at high risk for radiation toxicity
* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Pregnant or lactating women
* Prior allergic reaction to temozolomide
* Patients treated on any other therapeutic clinical protocols within 30 days prior to step 1 registration or during participation in the study
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib
* Mean QTc >500 msec (with Bazett's correction) in screening electrocardiogram or history of familial long QT syndrome or other significant ECG abnormality noted within 14 days of treatment
* Patients receiving concurrent vascular endothelial growth factor (VEGF) inhibitors are prohibited from participating in this study
* Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED); patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs; in patients who have previously been on EIAED there must be at least a 14 day period since the last dose of an EIAED before the first dose of cediranib | 15,476 |
Study Objectives
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels.
This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors.
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication.
For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.
Conditions: Soft Tissue Neoplasms
Intervention / Treatment:
| INCLUSION CRITERIA
All patients must have pain poorly controlled by conventional methods, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication, as determined by the patient along with the palliative care/ pain consult service and/or the patient's physician.
Persistent or recalcitrant pain will be localized to a specific neoplastic lesion determined by consensus review by the P.I. with the pain/palliative care service, the patient's physician, and the diagnostic radiologist reviewing the case. Only patients with a limited number of lesions causing pain will be enrolled, and only if there is a target lesion which can be the focus of ablation.
All patients must have had a diagnostic CT scan which conclusively reveal a soft tissue metastasis, which is the source of pain as determined by the Palliative care oncologist. One independent radiologist who is not a co-investigator in this study must confirm this. Tumor does not have to be completely destroyable by RFA, as patients may benefit from simple debulking, denervation, or decrease in intratumoral pressure.
Age greater than or equal to 18 years.
Biopsy of lesion in question for histologic or cytologic confirmation of cancer will be obtained when safe and clinically indicated, or if there is reasonable doubt as to diagnosis. Reasonable doubt will be determined by the PI, the surgeon, and the palliative care oncologist by consensus.
Performance Status ECOG 0-2.
Life expectancy of 3 months or greater.
Platelet count greater than 50,000/mL, absolute granulocyte count (AGC) greater than 1,000/mL, serum creatine less than 1.5 mg/dl (or if greater than 1.5, measured creatine clearance greater than 50mL/min). Any patient with elevated PTT or PT that is uncorrectable will be evaluated by NIH hematology for safety of procedure. This will allow patients with "falsely-elevated" values to undergo the same evaluation that they would have for surgery or other invasive procedure. Dr. Horne is the hematologist and coinvestigator on this protocol.
No serious concurrent medical illness.
Bi-dimensionally measurable disease by radiographic means or physical examination.
The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question will be reviewed by the ethics committee.
Consult with an NCI surgeon and Palliative care oncologist who will determine if the patient's pain medications and other options (surgical) have been optimized prior to entry in this protocol. Surgical options must be either not possible, or rejected by the patient. Surgery will be either offered or ruled out as an alternative by the NCI surgeon prior to treatment.
Chemotherapy, radiation therapy, and classification of drug therapy must be stable without changes for 2 weeks prior to tumor ablation.
EXCLUSION CRITERIA
Patients with a coagulopathy which cannot be corrected, or a bleeding diathesis, will be excluded from this study. Patients taking anti-inflammatory agents or aspirin, heparin, heparinoids, or coumadin will be excluded until the prothrombin time and partial thromboplastin time have normalized.
Patients with an altered mental status that precludes understanding or consenting for a procedure will be excluded from this study.
Pregnant or nursing women and women of childbearing potential unless using effective contraception as determined by the patient's physician.
Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
Patients should not change the class of pain medication for two weeks prior to treatment and are ineligible if class is changed within two weeks prior. If the class of pain medication is switched within two weeks after treatment, the patient becomes inevaluable. | 15,767 |
Study Objectives
Assessments of mechanical skin sensitivity include psychophysical responses to stimulation with calibrated polyamide monofilaments.
One of the applications of polyamide monofilaments are the assessments of magnitude of secondary hyperalgesia areas (SHAs), i.e. areas in normal skin near an injury with increased mechanical sensitivity.
The objective of the study is to investigate the hypothesis, based on previous studies, that a light tactile stimulus delineates a larger SHA than stimulation with a more rigid monofilament.
Twenty-three healthy participants were included in this randomized, two-observer, test-retest study.
A highly significant positive correlation between the bending force of the polyamide filaments and the magnitude of SHA was demonstrated. The "weighted-pin" instrument showed significantly and consistently larger areas than the polyamide monofilaments.
The hypothesis was rejected: a light tactile stimulus did not delineate a larger secondary hyperalgesia area than stimulation with a more rigid monofilament. The "weighted-pin" instrument seems an alternative to the conventional polyamide monofilaments.
Conditions: Measurements of Areas of Secondary Hyperalgesia
Intervention / Treatment:
| Inclusion criteria:
* Healthy
* Age ≥18 years and ≤ 35 years
* Written informed consent
* Urine sample without any trace of opioids (morphine, methadone, buprenorphin)
* Body Mass Index: 18 < BMI < 32 kg/cm2
Exclusion criteria:
* Inadequate psychomotor ability to cooperate
* Inability to understand Danish or English
* Participated in another study in the preceding 60 days
* Known neurological disease
* Use of psychoactive drugs (benzodiazepines, SSRI, TCA, SNRI)
* Alcohol or drug abuse
* Chronic pain
* Use of pain medication on a regular basis
* Skin lesions in the examination area
* Use of prescription medicine 1 week before examination
* Use of over-the-counter (OTC) drugs 48 hours before examination
* Smoker | 34,357 |
Study Objectives
In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
Conditions: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Intervention / Treatment:
DRUG: melphalan, PROCEDURE: autologous hematopoietic stem cell transplantation, PROCEDURE: autologous bone marrow transplantation, PROCEDURE: peripheral blood stem cell transplantation, RADIATION: total-body irradiation, PROCEDURE: peripheral blood stem cell transplantation, DRUG: cyclosporine, DRUG: mycophenolate mofetil, BIOLOGICAL: therapeutic allogeneic lymphocytes
| Inclusion Criteria:
* Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease
* The patient must have the capacity to give informed consent
* Have received at least 4 cycles of conventional dose chemotherapy for MM
* DONOR: HLA genotypically identical sibling
* DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI
* DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
* DONOR: Age < 75, older donors may be considered after consultation by Psychological Consultation Center (PCC)
Exclusion Criteria:
* Karnofsky score less than 60, unless due solely to myeloma
* Left ventricular ejection fraction less than 40%
* Bilirubin greater than 2 X the upper limit of normal
* Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 X the upper limit of normal
* Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen
* Patients with poorly controlled hypertension
* Pregnancy
* Seropositive for the human immunodeficiency virus
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Creatinine clearance < 40 cc/min at the time of initial autografting evaluation
* Prior autograft (can be treated on alternative protocol)
* DONOR: Identical twin
* DONOR: Age less than 12 years
* DONOR: Pregnancy
* DONOR: Infection with human immunodeficiency virus (HIV)
* DONOR: Inability to achieve adequate venous access
* DONOR: Known allergy to G-CSF
* DONOR: Current serious systemic illness
* DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution | 31,201 |
Study Objectives
The purpose of the study is to test the safety and effectiveness of IDN-6556 in preventing liver damage that normally occurs when livers are transported before being transplanted and in the immediate post-transplant period.
Conditions: Liver Transplantation, Hepatitis, Cholestasis, Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: IDN-6556, DRUG: Placebo
| Inclusion Criteria:
* Minimum adult age
Exclusion Criteria:
* Fulminant hepatic failure (UNOS Status I patients)
* Previous liver transplantation
* Patients undergoing split liver grafts
* Extrahepatic malignancy
* If female, pregnant or lactating | 32,889 |
Study Objectives
Laparoscopic surgery has not changed much in safety compared with open surgery through many existing studies, and has become a procedure to help patients' recovery.
Recently, laparoscopic surgery has been actively performed for pancreaticoduodenectomy, one of the most complicated procedures in intraperitoneal surgery.
the investigators will perform a prospective study to establish a higher level of evidence for the efficacy and safety of laparoscopic pancreaticoduodenectomy.
The purpose of this study was to compare the short-term clinical outcomes including the functional recovery after surgery, complications and confirm that laparoscopic pancreaticoduodenectomy is safe and appropriate. This study includes an interim analysis and can be terminated early by analysis at the completion of 50% of planned patients.
Conditions: Functional Recovery, Laparoscopy, Periampullary Cancer
Intervention / Treatment:
PROCEDURE: Laparoscopic group
| Inclusion Criteria:
* Age: 19 to 80 years
* Performance: Eastern Cooperative Oncology Group (ECOG) 0-2
* The preoperative examination showed that the lesion could not be invaded by major blood vessels.
* No distant metastasis
* Bone marrow function: white blood cell (WBC) at least 3,000 / mm3, Platelet count at least 100,000 / mm3
* Kidney function: Creatinine no greater than 1.5 times upper limit of normal.
* Patients who consented to and signed the consent
Exclusion Criteria:
* Severe obesity (BMI> 30)
* Those with active or uncontrolled infections
* Those with severe psychiatric / neurological disorders
* Alcohol or other drug addicts
* Patients included in other clinical studies that may affect this study
* Patients who cannot follow the directions of the researcher
* Those with uncontrolled heart disease
* Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)
* Pelvic tumor, benign tumor, malignant tumor in other organs
* Patients who received prior chemotherapy
* In addition to the planned PD patients who require resection of other major abdominal organs (such as gastrectomy, colonic resection and portal / upper mesenteric vascular resection, more than standard PD) | 33,846 |
Study Objectives
Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant primary brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified, conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it may establish an active infection by replicating in and killing tumor cells.
Conditions: Glioblastoma or Gliosarcoma
Intervention / Treatment:
DRUG: Single intratumoral injection of DNX-2401, DRUG: Interferon-gamma
| Inclusion Criteria:
* Glioblastoma or gliosarcoma in first or second recurrence only
* Documented tumor recurrence or progression after failing prior surgical resection, chemotherapy, or radiation
* Tumor size greater than or equal to 1.0 cm in two perpendicular diameters
* Not undergoing surgical resection or for whom gross total resection is not possible
* Karnofsky Performance Status greater than or equal to 70%
Exclusion Criteria:
* Multiple intracranial malignant glioma lesions
* Tumor location or involvement that would result in risk of ventricular penetration during tumor injection
* Tumor involving both hemispheres or that which involves the subependyma or suspected cerebrospinal fluid dissemination
* Tumor involving brain stem
* Documented extracranial metastasis
* Inability to undergo MRI
* Pregnant or nursing females
* Any medical condition that precludes the surgery necessary to administer DNX-2401 into the tumor using the cannula
* Immunocompromised subjects or those with autoimmune conditions, active hepatitis or positive for human immunodeficiency virus (HIV)
* Li-Fraumeni Syndrome
Other protocol-defined inclusion/exclusion criteria may apply as outlined in the relevant protocol version | 11,900 |
Study Objectives
The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days.
Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.
Conditions: Malignant Glioma
Intervention / Treatment:
DRUG: Doxorubicin
| Inclusion Criteria:
* Patients having received at least one cycle of chemotherapy after radiotherapy
* Patients having grade III or IV (WHO) glioma, not localized in brainstem
* Tumor measurable with magnetic resonance imaging
* Absence of other concomitant anti-cancer treatments
* Absence of chemotherapy for 4 weeks; 6 weeks if nitrosourea
* Good general health and nutritional status according to NCI-CTC scale (version 3) (appendix 6)
* Lansky score > 50% or Karnofsky > 50 in children older than 12 years
* Absence of organ toxicity (grade > 2 according to NCI-CTC criteria (version 3)
* Hematology: polynuclear neutrophil count > 1.0 x 109/l
* Hematology: platelet count > 100 x 109/l
* Liver function: bilirubinemia < 1.5 normal value
* Liver function: ASAT and ALAT levels < 2.5 normal values
* Liver function: prothrombin level > 70%
* Liver function: fibrinogen > 1.5 g/l
* Renal function: creatinemia < 1.5 normal value/age
* Cardiac function: EF > 60% and/or SF > 30%
* Signature of informed consent by patient if adolescent, by 2 parents or legal guardian if minor patient
* For patients with childbearing potential, a contraceptive method is compulsory. This contraception must be continued 6 months after Myocet treatment end
* For patients with childbearing potential, negative pregnancy test (betahCG test)
Exclusion Criteria:
* Non compliance with eligibility criteria
* Severe or life-threatening infection
* Non controlled evolutive or symptomatic intracranial hypertension
* History of Myocet treatment, but patients could be treated with anthracyclines if cardiac function is normal
* Hypersensibility to the active substance, to premixtures or one of excipients
* Pregnancy and breastfeeding | 14,129 |
Study Objectives
Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it.
The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated.
Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).
Conditions: Dysphagia, Head and Neck Cancer
Intervention / Treatment:
OTHER: Swallowing exercise from home
| Inclusion Criteria:
* prior diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma (OPSCC)
* 3 months or later post-surgery or post-(chemo)radiation therapy
* received treatment for head and neck cancer (e.g., +/-surgery, +/-radiation therapy, +/- chemotherapy)
* attending speech-language pathologist has confirmed from a Modified Barium Swallow (MBS) assessment or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) that the patient is a candidate for the effortful swallow and/or the Mendelsohn maneuver therapy.
Exclusion Criteria:
* have a history of cognitive delay (patient or SLP reported)
* have a history of stroke or traumatic brain injury (patient or SLP reported)
* cannot reliably navigate the Mobili-T system after the training session
* attending SLP confirms planned swallowing exercises or procedures to address dysphagia like esophageal dilation
* have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators
* have irritated skin or skin with open wounds under the chin
* have an allergy to silver
* have a beard or not willing to shave or partially shave
* unable to travel to Edmonton 3 times during a 3 month period | 31,292 |
Study Objectives
The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.
Conditions: Rectal Cancer
Intervention / Treatment:
OTHER: Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging), OTHER: MDT (Multidisciplinary team) meeting observation, OTHER: Semi-structured exploratory interviews and focus group with MDT health professional attendees
| Inclusion Criteria:
* Patients operable and/or capable of receiving a radiotherapy and/or a chemotherapy
* Patients in care in the French and Australian centres participating in the study
Exclusion Criteria:
* Patients suffering from primitive rectal cancer at a stage inferior to T4b
* Patients suffering from primitive locally-advanced metastatic rectal cancer (T4NxM1)
* Patients suffering from recurrence of metastatic rectal cancer
* Patients having been refused a surgical procedure because of one or multiple comorbidities | 29,875 |
Study Objectives
Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.
Conditions: Colorectal Carcinoma, Soft Tissue Sarcoma
Intervention / Treatment:
GENETIC: Next Generation Sequencing (NGS): exome, RNA seq
| Inclusion Criteria:
* Adult patients
* Disease: Advanced and/or metastatic soft-tissue sarcoma OR metastatic carcinoma
* Patient consenting to tumor sequencing, secondary reuse of their data
* Patient informed about this study
Exclusion Criteria:
* N/A | 16,463 |
Study Objectives
This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer that has spread to other places in the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving veliparib together with floxuridine may kill more tumor cells.
Conditions: Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
Intervention / Treatment:
DRUG: Floxuridine, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Veliparib
| Inclusion Criteria:
* Histologically confirmed epithelial ovarian, primary peritoneal or fallopian tube malignancy that is metastatic and for which standard curative measures do not exist
* Disease confined to the intraperitoneal and retroperitoneal cavity; Note: nodal disease below the diaphragm, implants adherent to the surface of the liver or intrahepatic lesions will not be exclusionary; patients remain eligible if all intrahepatic tumor is debulked or ablated by the time treatment is initiated
* EXPANSION PHASE ONLY: Evaluable or measurable disease with the largest nodule measuring less than 5 cm in greatest dimension by radiographic imaging after debulking procedure
* Candidate for and willingness to have a surgically placed intraperitoneal catheter and tissue acquisition at the time of port placement; note: if an intraperitoneal catheter is already in place, a tumor biopsy will still be required; a guided core-needle biopsy is sufficient in these cases
* Able to swallow and absorb the medication
* Obtained =< 7 days prior to registration: Absolute neutrophil count (ANC) >= 1500/mm\^3
* Obtained =< 7 days prior to registration: Platelets (PLT) >= 100,000/mm\^3
* Obtained =< 7 days prior to registration: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
* Obtained =< 7 days prior to registration: Creatinine =< 1.5 x institutional ULN
* Obtained =< 7 days prior to registration: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional ULN
* Obtained =< 7 days prior to registration: Hemoglobin (Hgb) > 9.0 mg/dl
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Ability to provide informed written consent
* Life expectancy >= 12 weeks
* Women of childbearing potential only: negative pregnancy test done =< 7 days prior to registration
Exclusion Criteria:
* Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy; note: patients with recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube will be allowed, if the investigator believes the study treatment is a better alternative to initiation platinum-based chemotherapy, such as patients with a prior platinum allergy or low volume disease for whom platinum-based therapy is deferred until a later date
* More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other 'targeted' agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Any of the following prior therapies:
* Chemotherapy =< 28 days prior to registration
* Mitomycin C/nitrosoureas =< 42 days prior to registration
* Immunotherapy =< 28 days prior to registration
* Biologic therapy =< 28 days prior to registration
* Radiation therapy =< 28 days prior to registration
* Investigational therapy or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation) =< 28 days prior to registration
* Prior poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor therapy
* Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
* Significant cardiovascular disease defined as congestive heart failure (New York Heart Association class III or IV cardiac disease), angina pectoris requiring nitrate therapy or recent myocardial infarction (=< 6 months prior to registration)
* Metastatic disease outside the intraperitoneal cavity and retroperitoneum, intrahepatic lesions, or pleural effusions; significant ascites precluding catheter placement; exception: intrahepatic lesions removed or planning to be removed during the debulking procedure
* Any of the following:
* Nursing women
* Pregnant women
* Women of childbearing potential who are unwilling to employ adequate contraception (non-barrier method)
* Immunocompromised patients (other than that related to the use of corticosteroids) with the exception of patients known to be human immunodeficiency virus (HIV) positive and have a cluster of differentiation 4 (CD4) count > 400 and do not require antiretroviral therapy
* Receiving any other investigational agent that would be considered a treatment for the primary neoplasm
* Other active malignancy =< 1 year prior to registration
* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer | 32,494 |
Study Objectives
The overall goal of this study is to examine the effect of a single dose of TENS on mucositis pain and function secondary to head and neck radiation therapies. Oral mucositis is an extremely debilitating, unpreventable condition (inflammation, ulcers, bleeding in the mouth, nose, and throat) that causes significant pain, functional impairment, and diminished quality of life. Head and neck cancers pose specific challenges to effective pain management and past studies suggest the use of effective non-pharmacologic strategies such as TENS may be particularly beneficial for avoiding sources of acute and chronic pain, thereby improving quality of life. The investigators hypothesize that a single dose of TENS will decrease pain and improve function and quality of life in head and neck cancer patients. This project is particularly innovative because it is the first known study to examine the efficacy of TENS, an established safe, inexpensive and easy-to-use non-pharmacologic pain management intervention, for treating acute oral mucositis pain. The investigators research translates bench (animal model) science to human subjects using an interdisciplinary approach to pain management. Establishing whether TENS is effective for reducing mucositis pain is a critical first step toward establishing an effective, non-pharmacologic pain relief intervention for mucositis.
Conditions: Head Cancer, Neck Cancer, Pain
Intervention / Treatment:
DEVICE: Transcutaneous Electrical Nerve Stimulation (TENS)
| Inclusion Criteria:
* Head and Neck Cancer Diagnosis
* Oral mucositis diagnosis
Exclusion Criteria:
* TENS use ≤ 5 years
* Pacemaker
* Pregnancy | 7,011 |
Study Objectives
This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of 2 doses of GSK525762 administered as besylate tablet.
Conditions: Carcinoma, Midline
Intervention / Treatment:
DRUG: GSK525762
| Inclusion Criteria:
* Male or female 16 years or older, at the time of signing the informed consent.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is less than 18 years old, an Assent form and parental/guardian Consent form (replacing "you will" with "your child will" will be required).
* Diagnosis of one of the following: Part 1 Only: NUT Midline Carcinoma based on ectopic expression of NUT protein as determined by IHC and/or detection of NUT gene translocation as determined by FISH. Subjects may be treatment naïve or have had prior therapy; SCLC, CRC, NB, TNBC, ER positive BC, CRPC, NSCLC and any other solid tumor which has been confirmed by clinical testing to be MYCN amplified (defined as a MYCN gene copy number gain of >=5). Subjects should have tumor progression after receiving at least one prior standard/approved chemotherapy, or where there is no approved therapy, or where standard therapy is refused. Part 2 only: NUT Midline Carcinoma as diagnosed by the Central Laboratory. Subjects may be treatment naïve or have had prior therapy. SCLC, CRPC, TNBC and ER+BC .
* Subjects with solid tumors, with the exception of CRPC, must demonstrate measurable disease, per RECIST v1.1. NOTE: Subjects with NMC that do not meet the RECIST v1.1 criteria for measurable disease, but have evaluable disease may be considered for enrollment after discussion with the GSK medical monitor..
* All prior treatment- related toxicities must be CTCAE (Version 4.0) <=Grade 1 (except alopecia and peripheral neuropathy) at the time of treatment allocation \[NCI-CTCAE, 2009\].
* ECOG Performance Status score of 0 or 2 for subjects with NMC; 0-1 for subjects with other tumor types.
* Adequate organ function as follows: Hematologic system: Absolute neutrophil count (ANC), Lab values - >=1.5 X 10\^9/L; Hematologic system: Hemoglobin, Lab values - >=9.5 grams/deciliter (g/dL) (subjects that required transfusion or growth factor need to demonstrate stable haemoglobin for 7 days of 9.5 g/ g/dL); Hematologic system: Platelets, Lab values - >=100 X 10\^9/Liter \[L\] ); Hematologic system: Prothrombin time /International normalized ratio and partial thromboplastin time, Lab values - <=1.5 X upper limit of normal (ULN). Renal system: Creatinine, lab values - <=1.5 X ULN; or Renal system: Calculated creatinine clearance \[calculated by Cockcroft Gault formula\], lab values - >=50 milliliter (mL)/minute (min); or Renal system: 24-hour urine creatinine clearance>=50 mL/min; Hepatic system: total Bilirubin <=1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >=2.5 x ULN. Cardiac system: Ejection fraction, lab values - >=lower limit of normal (LLN) by Echocardiogram (ECHO) (minimum of 50%); Cardiac system: Troponin ( T), lab values - <=ULN; Cardiac system: Potassium, lab values - >=LLN and <=ULN; Cardiac system: Magnesium, lab values - >=LLN. Thyroid system: thyroid stimulating hormone, lab values >=LLN and <=to ULN. Reproductive /endocrine system: testosterone <50 nanogram (ng)/dL (only for subject with CRPC)
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 milli international unit/mL and estradiol less than 40 pg/mL (less than 140 pmol/L) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods (described in the protocol) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication; Negative serum pregnancy test <=7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.
* Male subjects must agree to use one of the methods of contraception specified. This method must be used from the time of the first dose of study medication until least 16 weeks after the last dose of study medication. In addition, male subjects whose partners are or become pregnant while on study medication must continue to use condoms for 7 days after stopping study medications.
* Specific eligibility criteria for Part 2 CRPC expansion cohort: Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma, surgically castrated or continuously medically castrated (for >=8 weeks prior to pre-screening).
* Specific eligibility criteria for Part 2 CRPC expansion cohort: Persistent disease with evidence of disease progression following standard therapy(ies) including prior treatment with androgen/androgen receptor directed therapy, including enzalutamide and/or abiraterone
* Specific eligibility criteria for Part 2 CRPC expansion cohort: Ongoing androgen deprivation therapy with a serum testosterone level <1.7 nanomoles/L or <50 ng/dL.
* Specific eligibility criteria for Part 2 CRPC expansion cohort: Prostate-Specific Antigen (PSA) levels >=2.0 ng/mL. Note: If PSA level has been obtained within 14 days of Screening, this test does not need to be repeated and the result previously obtained may be used for the Screening value.
Exclusion Criteria:
* Primary malignancy of the central nervous system or malignancies related to human immunodeficiency virus or solid organ transplant. History of known HIV. History of known Hepatitis B surface antigen or positive Hepatitis C antibody (confirmed by RIBA).
* Prior treatments usage as defined: A) Use of an investigational anti-cancer drug within 14 days or 5 half-lives, whichever is longer, prior to the first dose of the investigational products:; B) A minimum of 14 days between termination of the investigational drug and administration of GSK525762; C) Any therapy related toxicities must also have resolved to Grade 1 or less. Note that an investigational drug is defined as a drug without an approved oncologic indication; D) Chemotherapy, radiotherapy, anti-neoplastic antibody or targeted therapy or immunotherapy within 14 days, major surgery within 28 days (or 42 days for prior nitrosoureas or mitomycin C) prior to the first dose of the investigational product. Anti-androgen (e.g., bicalutamide) therapies for prostate cancer must be stopped 4 weeks prior to enrollment. Second line hormone therapies such as enzalutamide, abiraterone, or orteronel should be stopped 2 weeks prior to enrollment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be eligible for this study.
* Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762. Low dose (prophylactic) low molecular weight heparin (LMWH) is permitted. In addition, INR must be monitored in accordance with local institutional practices.
* Current use of a prohibited medication or requires any of these medications during treatment with the investigational drugs (details will be available in the protocol). This includes excluding current medications known or suspected to be associated QT prolongation. In addition, any subject who may require a QT prolonging medication while on trial should not be enrolled.
* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
* Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression. NOTE: Subjects previously treated for these conditions that have had stable central nervous system disease (verified with consecutive imaging studies) for >1 month, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted. Stability of brain metastases must be confirmed with imaging. Subject treated with gamma knife the can be enrolled 2 weeks post-procedure as long as there are no post-procedure complications/stable. In addition, subjects treated or currently taking enzyme-inducing anticonvulsant are allowed on study.
* Cardiac abnormalities as evidenced by any of the following: History or current "untreated" clinically significant uncontrolled arrhythmias; Clinically significant conduction abnormalities or arrhythmias, subjects with Bundle Branch Block; Presence of cardiac pacemaker; History or evidence of current >=Class II congestive heart failure as defined by New York Heart Association (NYHA); History of acute coronary syndromes (including unstable angina and myocardial infarction ), coronary angioplasty, or stenting within the past 3 months.
* Any of the following ECG findings: Baseline QTcF interval >=450 millisecond (msec); Any clinically significant ECG assessments should be reviewed by the site cardiologist prior to study entry.
* GSK525762 is a benzodiazepine class molecule. Any serious known immediate or delayed hypersensitivity reaction(s) to GSK525762 or idiosyncrasy to drugs chemically related to the investigational drug.
* Hemoptysis >1 teaspoon in 24 hours within the last 28 days.
* History of major gastrointestinal bleeding within the last 6 months. Any evidence of active gastrointestinal bleeding excludes the subject.
* Besylate Sub-Study only: unable or unwilling to eat the FDA recommended high-fat high-calorie breakfast (two eggs fried in butter, two strips of bacon, 4 ounce \[oz\]) of hash brown potatoes and 8 oz of whole milk) within the recommended 30 minutes. | 9,598 |
Study Objectives
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
Conditions: Breast Cancer, 2D Mammography, 3D Mammography
Intervention / Treatment:
DEVICE: tomosynthesis, DEVICE: 2D mammography
| Inclusion Criteria:
* woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
* age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
* breast size suitable for detector size
* possible prior mastectomy
* security social covered
* signed informed consent
Exclusion Criteria:
* breast implant
* high genetic risk (mutation)
* under justice measures
* breast feeding or pregnant woman | 4,822 |
Study Objectives
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Conditions: Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis
Intervention / Treatment:
DEVICE: PINPOINT Endoscopic Fluorescence Imaging System
| Inclusion Criteria:
* Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge)
* A negative pregnancy test for women of childbearing potential prior to surgery
Exclusion Criteria:
* Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
* Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
* Subject is a pregnant or lactating female | 38,179 |
Study Objectives
This randomized phase I/II trial studies the side effects and best dose of vaccine therapy and to see how well it works when given together with 1-methyl-D-tryptophan (1-MT) in treating patients with metastatic breast cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
Conditions: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
BIOLOGICAL: adenovirus-p53 transduced dendritic cell (DC) vaccine, DRUG: 1-methyl-d-tryptophan, OTHER: Laboratory biomarker analysis
| Inclusion Criteria:
* In the phase I patients with any solid tumor positive for p53 by IHC (>= 5% of cells with any degree of nuclear staining) staining; for the phase II, patients must have histologically or cytologically confirmed metastatic invasive breast cancer that is positive for p53 staining by IHC (>= 5% of cells with any degree of nuclear staining); patients will sign a separate consent for the p53 testing, and those that meet the above requirements will then be allowed to sign the vaccine trial consent
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
* There are no restrictions on prior therapies for the phase I part of the trial; for the phase II, patients may have received up to 2 prior lines of chemotherapy (not counting endocrine therapy lines) with the last dose of chemotherapy given 3 weeks (6 weeks for nitrosoureas and mitomycin C) prior to initiation on this study
* Life expectancy of greater than 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
* Leukocytes >= 3,000/μL
* Absolute neutrophil count >= 1,500/μL
* Platelets >= 100,000/μL
* Total bilirubin within normal institutional limits unless patient has Gilbert's disease
* Aspartate aminotransferase (AST) /serum glutamic oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT) /serum glutamic pyruvate transaminase (SGPT) =< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), adrenocorticotropic hormone (ACTH) showing normal pituitary function; these values may deviate if in the opinion of the investigator these are normal pituitary responses to another endocrine condition such as suboptimally treated hypothyroidism
* Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids
* No history of gastrointestinal disease causing malabsorption or obstruction such as but not limited to Crohn's disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection
* Sexually active women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; males should use barrier contraception or abstinence during the study; use of contraception or abstinence should continue for a minimum of 1 month after completion of the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should discontinue the study drug and inform her treating physician immediately; a pregnancy test is required prior to study enrollment and monthly while on treatment with 1-MT for all women of child-bearing potential; also men should be discouraged from fathering children while on treatment
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 3 weeks (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
* Patients may not receive any other investigational agents or chemotherapy to treat their underlying malignancy while on study; patients who are stable on prior endocrine therapies (i.e. aromatase inhibitors, tamoxifen, and fulvestrant) may stay on these treatments
* Patients with known untreated brain metastases are excluded from this clinical trial; patients with stable previously treated lesions in a patient off steroids and radiation for 1 month are not excluded
* History of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-D-tryptophan; this would include L-tryptophan or 5-hydroxy-tryptophan supplements
* No supplements containing L-tryptophan or derivatives thereof are allowed to be taken while on study; also ingestion of antacid compounds should be timed a minimum of 2 hours before or after ingestion of 1-MT
* Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (\[IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study; any patient with an allo-transplant of any kind would be excluded as well; this would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration; mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded
* Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction or percutaneous coronary interventions within the last 6 months, cardiac arrhythmia, active autoimmune diseases, or major psychiatric illness/social situations that would limit compliance with study requirements as judged by the primary investigator at each site; those with well controlled, chronic medical conditions under the supervision of the patient's primary physician (i.e. hypertension, hyperlipidemia, coronary heart disease, diabetes mellitus) would not be excluded
* Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with 1-methyl-D-tryptophan
* Human immunodeficiency virus (HIV)-positive patients and those with other acquired/inherited immunodeficiencies are ineligible
* Patients with more than one active malignancy at the time of enrollment
* Patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies or pharmaceutical compounds are excluded; prior experimental vaccine patients may be enrolled if approved by the principal investigator (PI); patients who have received commercially available active immunotherapies such as adjuvant interferon must have completed therapy over 1 year prior to enrollment and have no evidence of autoimmune sequelae; prior therapy with approved monoclonal antibodies such as bevacizumab, cetuximab, panitumumab, or trastuzumab is allowed; concurrent treatment with these agents and the study treatment is not allowed
* Human epidermal growth factor receptor 2 positive (HER2+) patients (IHC 3+ and/or fluorescent in situ hybridization \[FISH\] HER2/centromere portion of chromosome 17 \[CEP17\] ratio > 2) who require treatment with trastuzumab or lapatinib are not eligible for this study | 20,720 |
Study Objectives
Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
OTHER: Low Intensity steady state training, OTHER: High intensity interval training
| Inclusion Criteria:
* females 18 to 45 years of age
* Diagnosed with PCOS based on Rotterdam criteria
* Ferriman and Gallway score of >8 for hirsutism
Exclusion Criteria:
* Use of hormonal contraceptives or IUDs for contraception
* Taking metformin <3 months prior to the inclusion
* Breast feeding mothers
* Type I or II DM
* Hypo/hyperthyroidism
* Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance. | 7,063 |
Study Objectives
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Conditions: Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
Intervention / Treatment:
DRUG: PF-06946860
| Inclusion Criteria:
* Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
* Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI or If medical record documentation is unavailable, patient's report will suffice to estimate involuntary body weight loss.;
* Will receive the following for non-small cell lung cancer:
* a platinum + pemetrexed ± pembrolizumab or
* a platinum + nab paclitaxel or paclitaxel ± pembrolizumab or
* pembrolizumab alone
* Will receive the following for pancreatic cancer:
* FOLFIRINOX or
* Nab-Paclitaxel + Gemcitabine
* Gemcitabine
* Will receive the following for colorectal cancer:
* FOLFOX +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* FOLFIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* FOLFOXIRI +/- Biologic (Bevacizumab or Cetuximab/Panitumumab) or
* Pembrolizumab for MSI-H * Will be entering the study at the first or second cycle of their current course of anti-cancer treatment/ therapy.
* Adequate renal and liver function.
* Signed informed consent.
Exclusion Criteria:
* All other forms of cancers not specified above unless currently considered cured (>5 years without evidence of recurrence).
* Planned radiation therapy as part of the primary anti-tumor therapy regimen. However, localized radiation therapy for symptomatic relief is permitted
* Cachexia caused by other reasons: Severe COPD requiring use of home O2, heart failure or AIDS.
* known symptomatic brain metastases requiring steroids.
* Active hepatitis B or C virus.
* Confirmed positive HIV test.
* Current active reversible causes of decreased food intake.
* Receiving tube feedings or parenteral nutrition at Screening.
* Elevated blood pressure that cannot be controlled by medications.
* Women who are pregnant or breast-feeding | 14,556 |
Study Objectives
This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules.
Conditions: Lung Cancer
Intervention / Treatment:
PROCEDURE: Video-Assisted Thoracic Surgery (VATS) wedge resection
| Inclusion Criteria:
* peripheral lung nodules < 3cm in size
* Surgical candidate
Exclusion Criteria:
* Non surgical candidate | 35,535 |
Study Objectives
Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.
Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Ixabepilone, PROCEDURE: Prostatectomy
| Inclusion Criteria:
* Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine or transitional cell carcinomas are not eligible.
* All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
* Clinically Localized Disease: Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
* Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is required.)
* Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if necessary).(Positive PET and Prostascint scans are not considered proof of metastatic disease.)
* Patients must have high risk disease defined as either:
* Gleason Score 8-10
* PSA > 15 ng/ml
* Stage T3a
* Stage T2c and Gleason score of 7
* Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a single lobe.
* No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
* Patient must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by an urologist.
* ECOG PS 0-1
* Age > 18 years of age.
* Required initial laboratory values:
* ANC > 1500/ul
* Platelet count > 100,000/mm3
* Creatinine < 2.0 mg/dl
* Serum PSA < 100 ng/ml
* Bilirubin < upper institutional limit of normal (ULN)
* AST/ALT < 2.5 X ULN
Exclusion Criteria:
* Active or uncontrolled infection.
* Patients must not have other coexistent medical condition that would preclude protocol therapy.
* Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).
* Grade 1 or greater neuropathy (motor or sensory) at study entry | 19,695 |
Study Objectives
The primary objective of this study was to evaluate the safety and pharmacokinetics of up to 3 different dose schedules of panitumumab in pediatric patients with solid tumors.
Conditions: Solid Tumors
Intervention / Treatment:
BIOLOGICAL: Panitumumab
| Inclusion Criteria:
* Parents or legal guardian signed-written informed consent
* 1 to < 18 years of age
* Histologically or cytologically confirmed solid tumor that has recurred after standard therapy, or for which there is no standard therapy. Subjects with brainstem glioma DO NOT need histologic proof of the diagnosis.
* Paraffin-embedded tumor tissue from primary tumor or metastasis for determination of epidermal growth factor receptor expression and biomarker testing
* Central nervous system tumors are allowed
* Presence of measurable or non-measurable disease.
* Life expectancy of ≥ 12 weeks.
* Performance status: Karnofsky ≥ 60% for 12 to <18 years of age; Lansky play scale ≥ 60% for 1 to < 12 years of age.
* Adequate hematologic function.
* Adequate renal function.
* Adequate hepatic function.
* Magnesium ≥ lower limit of normal (LLN)
* Adequate pulmonary function
* All previous therapy-related toxicities must have resolved or return to baseline.
Exclusion Criteria:
* Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease or other hematologic malignancy.
* Any prior allogeneic transplant.
* Prior autologous bone marrow or peripheral stem cell transplant less than 3 months prior to enrollment.
* Substantial radiotherapy to the bone marrow within 6 weeks prior to enrollment.
* Prior use of any monoclonal antibodies directly targeting the epidermal growth factor receptor (EGFr). Subjects who have received prior tyrosine kinase inhibitors such as gefitinib or erlotinib are eligible.
* Immunotherapy, radiotherapy, or chemotherapy ≤ 2 weeks prior to enrollment. (≤ 6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin, and ≤ 6 weeks from prior antibody therapy).
* Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy (except for pain control) or any other investigational drug while on this study.
* Prior seizures < 3 months prior to enrollment. Subjects with a history of seizure disorders ≥ 3 months prior to enrollment must be seizure free and on stable anticonvulsant medication(s) for ≥ 3 months prior to enrollment).
* Presence of a serious uncontrolled medical disorder.
* Dementia, altered mental status, or any other medical condition or disorder that would prohibit the understanding or rendering of assent (if applicable), or ability to comply with study procedures.
* Major surgery ≤ 28 days prior to enrollment.
* Known or suspected history of interstitial lung disease.
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea.
* Known positive test for human immunodeficiency virus infection, hepatitis C virus, acute or chronic hepatitis B infection, or any co-morbid disease that would increase risk of toxicity.
* Females of childbearing potential not using adequate contraception precautions for the duration of the study treatment and for 2 months after the last administration of investigational product.
* Pregnant or breast-feeding, or planning to become pregnant during study treatment and within 2 months after the last administration of investigational product.
* Received investigational therapy or procedure ≤ 30 days prior to enrollment. | 18,938 |
Study Objectives
The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.
Conditions: Relapsed/Refractory Multiple Myeloma
Intervention / Treatment:
DRUG: Ixazomib
| Inclusion Criteria:
* All patients who have been confirmed as administration of the drug.
Exclusion Criteria:
* None | 32,238 |
Study Objectives
This is a phase II open-label trial designed to evaluate the efficacy of tocilizumab in improving GVHD-free/relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancy.
Conditions: Hematologic Malignancy
Intervention / Treatment:
DRUG: Tacrolimus, DRUG: Methotrexate, DRUG: Tocilizumab
| Inclusion Criteria:
* Age ≥18 years.* Patients with any hematologic malignancy for which alloHCT is indicated. Patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) must be in complete remission at the time of alloHCT(<5% blasts in the bone marrow, normal maturation of all cellular components in the bone marrow and absence of extramedullary disease).* Myeloablative conditioning (MAC) regimen, based on Center for International Blood and Marrow Transplant Research (CIBMTR) criteria.* T cell-replete peripheral blood graft.* Patients must have a matched related or unrelated donor (at least 6/6 match at human leukocyte antigens (HLA) -A, -B and -C for related donors and at least 8/8 match at HLA-A, -B, -C and -DRB1 for unrelated donors).* Cardiac function: Left ventricular ejection fraction ≥45% for myeloablative conditioning.* Estimated creatinine clearance ≥40 mL/minute (using the Cockcroft-Gault formula and actual body weight).* Pulmonary function: Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% (adjusted for hemoglobin) and Forced Expiratory Volume (FEV1) ≥50%.* Liver function: total bilirubin <3 x upper limit of normal and alanine aminotransferase (ALT) / aspartate aminotransferase (AST) <5 x upper normal limit.* Signed informed consent: Voluntary written consent must be given before patient registration and performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.* Female patient: A negative pregnancy test will be required for women of child bearing potential. Breast-feeding or lactation is not permitted.* Planned posttransplant maintenance therapy is allowed.
Exclusion Criteria:
* Prior allogeneic HCT.* Active central nervous system (CNS) involvement with malignancy.* Patients receiving cord blood or haploidentical allograft.* Patients undergoing in vivo or ex vivo T cell-depleted alloHCT.* Karnofsky Performance Score <60%.* Patients with uncontrolled bacterial, viral or fungal infections (currently on treatment and with progression of infectious disease or no clinical improvement) at time of enrollment.* Active hepatitis B or C virus infection or known human immunodeficiency virus (HIV) positive.* Prior intolerance or allergy to tocilizumab.* Use of rituximab, alemtuzumab, anti-thymocyte globulin (ATG) or other monoclonal antibody planned as part of conditioning regimen for GVHD prophylaxis.* History of diverticulitis, Crohn's disease or ulcerative colitis.* History of demyelinating disorder.* Any current uncontrolled cardiovascular conditions, including uncontrolled ventricular arrhythmias, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled angina, or electrocardiographic evidence of active ischemia or active conduction system abnormalities.* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. | 17,236 |
Study Objectives
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Conditions: Cancer of Kidney, Kidney Cancer, Renal Cancer, Neoplasms, Kidney, Renal Neoplasms, Renal Cell Carcinoma (RCC), Clear Cell Renal Cell Carcinoma
Intervention / Treatment:
DRUG: 124-Iodine-cG250 (124I-cG250)
| Inclusion Criteria:
* Presence of a renal mass.* Scheduled for surgical resection of renal mass.* Expected survival of at least 3 months.* Karnofsky performance scale ≥70.* The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L
* Platelet count ≥ 100 x 10E9/L
* Serum bilirubin ≤ 2.0 mg/dL
* Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Serum creatinine ≤ 2.0 mg/dL* Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.* Recovered from toxicity of any prior therapy.* Able and willing to give valid written informed consent.
Exclusion Criteria:
* Intercurrent medical condition that may limit the amount of antibody to be administered.* Intercurrent medical condition that renders the patient ineligible for surgery.* New York Heart Association Class III/IV cardiac disease.* History of autoimmune hepatitis.* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.* Lack of availability for immunological and clinical follow-up assessments.* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.* Women who are pregnant or breastfeeding.* Allergy to iodine. | 29,237 |
Study Objectives
Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations.
This is a post-market, non-randomized multi-center surveillance study.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: Imagio IUS, DEVICE: Imagio OA/US
| Inclusion Criteria
* Female
* 18 years of age or older
* Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan
Exclusion Criteria:
* Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos)
* Pregnant or lactating
* Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU | 35,982 |
Study Objectives
Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow and mature, there are more androgen producing cells. Women with PCOS have more follicles than normal women and therefore more androgen producing cells. While androgen production has been associated with the number of follicles, the relationship to the individual size of follicles in PCOS or normal women. This study intends to determine whether the size and number of ovarian follicles are correlated to androgen production in PCOS and normal women.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
DRUG: hCG
| Inclusion Criteria:
* Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound* Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start* Subjects will be determined to be normal controls if they have a clinical history of regular periods
Exclusion Criteria:
* Women with hemoglobin less than 11 gm/dl at screening evaluation* Women with untreated thyroid abnormalities* Pregnant women or women who are nursing* Women with BMI > 37* Women with known sensitivity to the agents being used* Women with diabetes, or renal, liver, or heart disease | 36,992 |
Study Objectives
To prove that the efficacy and safety of 'Green Cross CELL\* Immuncell-LC group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(PEIT, RFA or operation) for hepatocellular carcinoma in Korea
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
BIOLOGICAL: Immuncell-LC
| Inclusion Criteria:
* Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
* The patient is more than 20 and less than 80 years old
* The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
* Child-Pugh Score should be less than 6 (refer to the attached file 7)
* No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (PEIT, RFA or operation) in 12 weeks. (based on the agreement date for written consent) The tumor's removal should be perfectly confirmed by pathological or radiological test with the mentioned method in 3) at least 4 weeks later.
* ECOG Performance status (ECOG-PS) is less than 1 or equal to (refer to the exhibit 8)
* Patient's remaining life-time should be expected at least more than 3 months.
* Patient should meet below conditions by blood test, kidney and liver function test
: Re-evaluation is possible during screening
* Leukocyte count is bigger than (3 multiply 109/L)
* Absolute Neutrophil Count (ANC) is bigger than or equal to 1,000/µL
* Hemoglobin is bigger than or equal to 8.5 g/dL
* Thrombocyte count is bigger than (5 multiply 1010/L)
* BUN and serum Creatinine is less than or equal to 1.5 multiply normal upper-limit
* No more disease abdominal extrahepatic transfer is confirmed by abdominal CT/ MRI
Exclusion Criteria:
* Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
* The carcinoma has been invaded to main portal vein or major branch hepatic vein
* Child-Pugh score is over 6
* Patient has serious problem with pulmonary function by sub- investigator's opinion
* Patient who has disease history of immune deficiency (which can be worse by immunotherapy) or auto-immune disease (ex. arthritis rheumatism, Burger's disease, multiple sclerosis and adolescent-occurred insulin dependent diabetes)
* Diagnosed as an immune deficiency patient
* Patient who has disease history of malignant tumor within 5 years before this clinical trial. (except for skin cancer, local prostate cancer or carcinoma in situ of the uterine cervix
* Patient who had anti-cancer medication before the clinical trial
* Patient who has serious disease in other organs after tumor resection.
* Patient has serious allergic-history by sub- investigator's opinion
* Patient has serious mental disease by sub- investigator's opinion
* Pregnant women, nursing mother or having intention of being pregnant during the clinical test
* Patient who participated in other clinical trial within 4 weeks before this clinical trial
* Patient who is incongruent to this clinical trial by sub- investigator's opinion. | 27,550 |
Study Objectives
This phase II trial is studying how well imatinib mesylate works in treating patients with metastatic or unresectable Merkel cell cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Conditions: Recurrent Neuroendocrine Carcinoma of the Skin, Stage II Neuroendocrine Carcinoma of the Skin, Stage III Neuroendocrine Carcinoma of the Skin
Intervention / Treatment:
DRUG: imatinib mesylate, OTHER: laboratory biomarker analysis
| Inclusion Criteria:
* Patients must have a biopsy-proven diagnosis of Merkel Cell Carcinoma (Cutaneous Neuroendocrine Carcinoma) that is distantly metastatic or unresectable
* Tumors must beet BOTH of the following criteria:
* The primary must be of skin origin; (patients with unknown primary are not eligible)
* All patients must have immunohistochemical staining with c-kit (CD117) expression by tumor documented by DAKO, Benchmark, or similar staining kit
* The institution must plan to submit materials for pathology review
* NOTE: Submission of additional specimens is strongly encouraged
* Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT or MRI scan or plain X-ray) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration
* Patients with symptomatic, unstable or untreated brain metastases are not eligible; previous treatment must have been completed at least 28 days prior to registration
* Patients must have a Zubrod performance status of 0-2
* Patients must not have received radiotherapy, chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration; all toxicities from prior treatment must have been resolved (in the opinion of the treating investigator); patients whose only disease is within a previous radiation therapy port must demonstrate clearly progressive disease prior to registration; patients must have resolution of all toxicities from any prior therapy to =< grade 1 (CTCAE version 3.0); patients must not have had a major surgery (e.g., large chest and abdominal incisions, major soft tissue resections) within 14 days prior to registration
* Serum bilirubin =< 3 x the institutional upper limit of normal (including those with hepatic metastases)
* SGOT or SGPT =< 2.5 x the institutional upper limit of normal (or =< 5 x the institutional upper limit of normal if hepatic metastases is present)
* Serum creatinine =< 1.5 x the institutional upper limit of normal
* ANC >= 1,000/ul
* Platelet count >= 100,000/ul
* Hemoglobin >= 9 gm/dl (this may be achieved by transfusion if needed)
* Patient must not have class 3/4 cardiac problems as defined by the New York Heart Association criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study)
* Patient must not have a sever and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g., HIV)
* Patients must not be pregnant or nursing; for women of reproductive potential, a negative serum pregnancy test must be done within 7 days prior to registration; post-menopausal women who have not had their ovaries removed must be amenorrheic for at least 12 months to be considered of non-childbearing potential; patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
* NOTE: oral contraceptives may interact with the study drug and should be used with caution
* Patients must not be taking therapeutic doses of Coumadin (warfarin) as anticoagulation at the time of registration; patients requiring therapeutic anticoagulation may use low molecular weight heparin (e.g., Lovenox) or other agents, and mini-dose Coumadin (1 mg po QD) as prophylaxis is allowed
* If day 7, 14, or 42 falls on a weekend or holiday, the limit may be extended to the next working day
* In calculating days of tests and measurements, the day a test or measurement is dose is considered day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base | 34,867 |
Study Objectives
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.
Conditions: Advanced Prostate Adenocarcinoma
Intervention / Treatment:
DRUG: AZD2171
| Inclusion Criteria:
* Men, 18yrs and older
* Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
* Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma
Exclusion Criteria:
* Prior radiotherapy to bone metastases within 4 weeks prior to screening
* any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week. | 7,898 |
Study Objectives
The goal of this research study is to learn about the beliefs, practices, and knowledge about cervical cancer among Asian American young adults. Researchers want to develop materials that will educate Asian Americans about cervical cancer and encourage them to get screened for this disease.
Conditions: Epidemiology
Intervention / Treatment:
BEHAVIORAL: Focus Group, BEHAVIORAL: Questionnaire
| Inclusion Criteria:
* Self identified as Korean, Filipino, or Vietnamese* Individuals 18-29 years of age* Have a high school education or less (but not less than 4th grade)* Able to read and speak English and one of these languages: Korean, Vietnamese, or Tagalog* Lower socioeconomic status, defined as: for a household of 1, not more than $18,620 annual income, for a household of 2, not more than $24,980, for a household of 3, not more than $31,340, for a household of 4, not more than $37,700, for a household of 5, not more than $44,060, for a household of 6,not more than $50,420, for a household of 7, not more than $56,780 NOTE: The CDC has granted some flexibility with these income guidelines* Not currently pregnant
Exclusion Criteria:
1) Household income greater than 200% of the federal poverty level | 34,116 |
Study Objectives
TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.
In this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403.
Conditions: Solid Tumors
Intervention / Treatment:
BIOLOGICAL: TB-403
| Inclusion Criteria:
* Confirmed malignity
* Measurable disease
* Performance status 1 or less (ECOG)
Exclusion Criteria:
* Acute illness or infection
* Concurrent second malignancy | 6,126 |
Study Objectives
The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
Conditions: Melanoma
Intervention / Treatment:
DRUG: Nilotinib, DRUG: DTIC
| Inclusion Criteria:
* Histologically confirmed mucosal or acral 2. Presence of a c-Kit mutation of exon 9, 11 or 13, or mutations Y822D and mutations D820Y, Y823D of exon 17, as confirmed by the central laboratory 3. Stage III unresectable or stage IV disease 4. The presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to RECIST 1.0. Lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. WHO performance status 0 - 2
Exclusion Criteria:
* C-Kit mutation of exons 17(except mutations D820Y, Y822D or Y823D) or any other exon not allowed by the inclusion criteria* Patients with c-Kit amplifications only and no mutation* Patients with any history of brain metastases* Patients who have had any prior treatment with TKIs* Patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit* Acute or chronic liver or renal disease considered unrelated to melanoma
Other protocol-defined inclusion/exclusion criteria may have applied. | 14,710 |
Study Objectives
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.
We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.
Conditions: Prostate Neoplasm
Intervention / Treatment:
DEVICE: MRI, PROCEDURE: MRI-targeted biopsy, PROCEDURE: TRUS-biopsy
| Inclusion Criteria:
* Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy* Serum PSA ≤ 20ng/ml within the previous 3 months* Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months* Fit to undergo all procedures listed in protocol* Able to provide written informed consent
Exclusion Criteria:
* Prior prostate biopsy* Prior treatment for prostate cancer* Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)* Contraindication to prostate biopsy* Men in whom artifact would reduce the quality of the MRI* Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work* Unfit to undergo any procedures listed in protocol | 16,324 |
Study Objectives
This is a phase II therapeutic study of adding exemestane therapy in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or nivolumab).
Conditions: Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Exemestane
| Inclusion Criteria
* Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
* Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase - tumor block or a minimum of 5 unstained slides
* Failed at least 1 prior FDA approved treatment for advanced NSCLC. Patients with EGFR/ALK/ROS1 rearrangements should have received an FDA-approved TKI prior to enrollment on this trial.
* Measureable disease by RECIST version 1.1
* Post-menopausal defined as
* Age ≥ 55 years and 1 year or more of amenorrhea
* Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL
* Surgical menopause with bilateral oophorectomy
* ECOG performance status 0, 1 or 2
\* Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record
* Adequate organ function within 14 days of study enrollment defined as:
* Hematology:
\*\* Absolute neutrophil count (ANC) ≥ 1500/mm³, Platelets ≥ 100,000/mm³, Hemoglobin ≥ 8 g/dL
* Biochemistry:
* Total Bilirubin within normal institutional limits
* AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
* Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min
* Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e. peripheral neuropathy) is permitted.
* A minimum time period must elapse between the end of a previous treatment and start of study therapy:
* 1 week from the completion of radiation therapy for brain metastases
* 4 weeks from the completion of chemotherapy or any experimental therapy
* 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
* Voluntary written consent before any research related procedures or therapy
Exclusion Criteria
* Known active CNS disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery - patients should be neurologically stable and requiring ≤10mg oral prednisone equivalence of steroids per day
* Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2
* Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity
* Inability or unwilling to swallow study drug
* Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
* Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
* Known hypersensitivity to exemestane or its excipients
* Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
* Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval
* Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane | 33,727 |
Study Objectives
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.
Conditions: Thoracotomy, Erector Spinae Plane Block, Thoracic Cancer, Shoulder Pain
Intervention / Treatment:
PROCEDURE: Thoracic Epidural Analgesia (TEA) group, PROCEDURE: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
| Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status class I and II.* Age ≥ 18 and ≤ 60 Years.* Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.
Exclusion Criteria:
* Patient refusal.* Local infection at the puncture site.* Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).* Unstable cardiovascular disease.* History of psychiatric and cognitive disorders.* Patients allergic to medication used. | 29,987 |
Study Objectives
Use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.
Conditions: Osteosarcoma, Pulmonary Metastases
Intervention / Treatment:
| Inclusion Criteria:
* Biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma);* Age no less than 12 years old and no older than 60 years old;* New-onset patients who have not received chemotherapy, radiotherapy, surgery, Chinese medicine and other treatments.* The primary site is the limbs and pelvis.
Exclusion Criteria:
* Pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma;* Failure to collect circulating exosomes as planned;* Suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , Chronic infections, etc.;* The use of targeted drugs may lead to a decrease in tumor-related circulating exosomes;* Withdrawal from the trial for any reason. | 13,104 |
Study Objectives
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
Conditions: Breast Density >25%
Intervention / Treatment:
PROCEDURE: 2D Mammogram, PROCEDURE: Tomosynthesis
| Inclusion Criteria:
* Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
* Prior mammogram report indicating ≥ 25% breast density.
Exclusion Criteria:
* Prior mammogram report indicating <25% breast density.
* Breast implants
* Pregnancy | 24,250 |
Study Objectives
Chronic inflammatory bowel disease (IBD) is associated with an increased risk of colorectal cancer (CRC) in historical cohorts. The pathways of oncogenesis of these CRCs, which are very different clinically from de novo CRCs, are currently unknown. The aim of our work is to identify specific molecular signatures of CRC occurring in the setting of IBD.
Conditions: Colorectal Cancer, Genetics of
Intervention / Treatment:
GENETIC: transcriptomic analysis
| Inclusion Criteria:
* Person 18 years of age or older
* Person with colorectal cancer in the context of IBD
* Person who has received complete information on the organization of the research and who has signed an informed consent
* Person affiliated to a social security plan or beneficiary of such a plan.
Exclusion Criteria:
* Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code:
* Pregnant woman, parturient or nursing mother
* Minor (not emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Person of legal age who is unable to express his or her consent
* Person deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1. | 36,101 |
Study Objectives
Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in reproductive-aged women, which associated with increased risks to develop metabolic disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular diseases. The precise pathogenesis of PCOS remains unknown but is thought to be multifactorial, comprising genetic and environmental factors .
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
OTHER: No intervention
| Inclusion Criteria:
* patients with obesity (BMI>28kg/m2)
* aged 18-45 years
* Diagnosis of PCOS
* the Rotterdam diagnosis criteria (2003)
Exclusion Criteria:
* Pregnant women;
* Hyperthyroidism or hypothyroidism
* Severe liver and kidney function injury
* Cancer patients;
* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
* Patients with mental illness or intellectual disability;
* Have taken drugs for PCOS treatment in the last three months;
* Taking drugs or foods (antibiotics, probiotics, yogurt, etc.) that affect the intestinal flora for nearly one month;
* Have a long history of taking hormone therapy;
* Currently or recently participating in another clinical trial. | 16,334 |
Study Objectives
1. Introduction Cervical cancer (CC) is a major public health problem in Low-income countries (LICs), particularly in the Democratic Republic of the Congo (DRC), where the estimated number of cases is 3839 per year. (WHO, 2010).
Persistent infection with Human Papillomavirus (HPV) is recognized as the necessary cause for the development of CC. Thus, CC is a disease that is easily preventable primarily by vaccination against HPV and secondarily through screening and treatment of precancerous lesions of the cervix.
In LICs, the high incidence of CC is due to both high rates of infection with HPV, a failure to initiate and sustain effective screening programs based on cytology and the non-availability of vaccination against HPV. These situations highlight the need to implement simple and inexpensive screening and treatment methods suitable for LICs. These methods include screening by visual inspection of the cervix after application of acetic acid (VIA) and treatment with a topical antiviral drug (AV2).
2. Aims
This study aims to:
* Evaluate the clinical efficacy of AV2 as a treatment for HPV-associated lesions of the uterine cervix;
* Identify HPV genotypes found in Kinshasa;
* Determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment;
3. Methods After basic training of local health workers on VIA, on collection of cervical samples for HPV testing (quantitative Polymerase Chain reaction, qPCR) and liquid-based cytology (LBC) and on application of AV2, a screening and treatment program will be offered to women aged 25 and older who will give their informed consent.
All women with lesions on VIA will be randomized into one of two groups to receive either treatment by AV2 or placebo.
All women with lesions on VIA will be monitored and reviewed after two months and after six months for repeat tests (VIA and LBC for lesions, qPCR for viral load, conversion and reinfection rates).
Conditions: Uterine Cervical Dysplasia, Papillomavirus Infections
Intervention / Treatment:
DRUG: AV2, DRUG: Placebo
| Inclusion Criteria:
* Sexually-active women
* Women with intact uterine cervix
* Voluntary written informed consent to participate in the study
Exclusion Criteria:
* Virgin women
* Pregnant or breast-feeding women, and women in the post-partum period
* Subject is already diagnosed with cervical cancer
* Medical history of any severe diseases like hepatitis, renal or liver dysfunction, cardiovascular, gastrointestinal, malignant tumor, or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator
* Intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of AV2®, or patients who plan to take such drugs during the trial
* Known or suspected allergic or adverse response to the investigational product AV2 or its components (olive oil or d-limonene)
* Inability to follow the study protocol | 16,730 |
Study Objectives
This is a Phase 1b, open-label, dose escalation study to evaluate the safety, tolerability, PK, and immunogenicity of an ADG116-pembrolizumab combination regimen in patients with advanced/metastatic solid tumors. Study drug ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. Pembrolizumab is a PD-1 receptor-blocking antibody (a humanized IgG4 monoclonal antibody) which is indicated for the treatment of patients across a number of indications. The treatment strategy of using anti-PD 1 therapy combined with anti-CTLA-4 therapy is to explore the potential of combination checkpoint inhibition regimens for the enhanced antitumor efficacy results.
Conditions: Advanced/Metastatic Solid Tumors
Intervention / Treatment:
DRUG: ADG116
| Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
1. ≥ 18 years of age at the time of informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.
3. Patients with advanced or metastatic solid tumors, histologically or pathologically confirmed, who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented.
4. Patients should have at least 1 measurable lesion at baseline according to the definition of RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
5. Patients previously treated with anti-CTLA 4 checkpoint inhibitors or anti programmed cell death 1 (PD-1)/L1 will also be recruited if they meet all eligibility criteria. For anti-PD-1/L1 patients, patients must have progressed on treatment with an anti PD 1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. Anti PD-1/L1 treatment progression is defined by meeting all of the following criteria:
1. Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
2. Has demonstrated disease progression (PD) after PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented PD, in the absence of rapid clinical progression.
3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
i. Progressive disease is determined according to iRECIST. ii. This determination is made by the Investigator. Once PD is confirmed, the initial date of PD documentation will be considered the date of disease progression.
6. Adequate hematologic function, defined by the following:
1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, without the use of granulocyte colony stimulating factor such as filgrastim within 2 weeks prior to study treatment.
2. Platelet count ≥ 100 × 109/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment.
3. Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.
7. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN. Exceptions: Patients who have serum bilirubin increases due to documented underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia may be enrolled. Patients with known liver metastases or patients with hepatocellular carcinoma may be enrolled with AST, ALT, and/or total bilirubin ≤ 5 × the ULN.
8. Adequate renal function defined by either a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine (SCr) ≤ 1.5 × ULN
9. Coagulation tests, defined by the following:
1. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
2. International normalized ratio (INR) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 × ULN is acceptable for patients on Warfarin anticoagulation.
10. Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO.).
11. Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) that has ended at least 4 weeks prior to administration of ADG116. Focal radiation therapy for symptom relief must have been completed at least 2 weeks prior to the first dose of ADG116. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease. Exception: hormonal therapy for prostate cancer is allowed (Section 6.7).
12. Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0 (except for patients with alopecia). Participants with Grade ≤ 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤ 2 requiring treatment or hormone replacement may be eligible.
Exclusion Criteria:
* Patients who meet any of the following criteria cannot be enrolled:
1. Pregnant or breastfeeding females.
2. Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 6 months after the last dose of study drug.
3. Treatment with any investigational drug within 4 weeks prior to the first dose of study drug.
4. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
6. History of severe hypersensitivity (Grade ≥ 3) or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 or pembrolizumab drug formulation.
7. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
8. Patients requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medications within 21 days before the planned first dose of study drug. Ophthalmologic, nasal, inhaled and intra-articular injections of steroids are allowed.
9. Patients receiving granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), erythropoietin, or blood (red blood cell \[RBC\] or platelet) transfusion within 14 days prior to the first dose of the study drug.
10. Any evidence of underlying liver dysfunction due to other causes; Any history of significant alcohol abuse, alcoholic or drug-induced hepatitis, or documented nonalcoholic steatohepatitis.
11. Active viral (any etiology) hepatitis patients are excluded. Hepatitis B virus (HBV) carriers are ineligible. Cured Hepatitis C (HCV) (negative HCV ribonucleic acid \[RNA\] test) patients may be enrolled after consulting with the Medical Monitor.
12. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled diabetes as evidenced by Screening (baseline) HbA1c≥ 7.5, asthma, chronic obstructive pulmonary disease (COPD), or other conditions that pose a risk to the patient participating on study.
13. Has a known history of HIV infection.
14. Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
15. Major surgery within 4 weeks prior to the first dose of the study drug.
16. Has had an allogeneic tissue/solid organ transplant.
17. Clinically significant cardiac conditions, including myocardial infarction within the last 6 months, uncontrolled angina, viral myocarditis, pericarditis, cerebrovascular accident, or other acute uncontrolled heart disease <3 months prior to the first dose of the study drug; LVEF <50%, New York Heart Association (NYHA) Class III or IV congestive heart failure, or uncontrolled hypertension.
18. Patients with underlying hemoglobinopathies (e.g., thalassemia) will be excluded.
19. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
20. Has received a COVID-19 vaccine within 7 days prior to the first dose of study treatment. Has received any other live or live-attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Administration of killed vaccines are allowed.
21. Has received a positive COVID-19 test within 14 days of Cycle 1 Day 1.
22. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
23. Any known, documented, or suspected history of illicit substance abuse.
24. Any other disease or clinically significant abnormality in laboratory parameters, including serious medical or psychiatric illness/condition, which in the judgment of the Investigator might compromise the safety of the patient or integrity of the study, interfere with the patient participation in the trial or compromise the trial objectives. | 8,133 |
Study Objectives
The purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. One in five women (in the US) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue.
In this study, researchers hope that the new SLI system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. If successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.
Conditions: Breast Cancer Female
Intervention / Treatment:
OTHER: Structured Light Imaging (SLI) System
| Inclusion Criteria:
* Females 18 years of age or older.* Histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy.* Scheduled for breast conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center* Ability to give an informed consent.
Exclusion Criteria:
* Patients who will have an expected specimen size greater than the specimen holder (i.e. > 10 X 10 X 5 cm).* Prisoners and cognitively impaired adults. | 28,355 |
Study Objectives
The purpose of this research study is to evaluate the effectiveness of transplantation of high doses of peripheral blood stem cells (stem cells are special cells found in the blood and bone marrow that produce new blood cells) after treatment with non-myeloablative chemotherapy (not toxic to the bone marrow). In addition, this study will assess the side effects of the transplant.
Conditions: Tumors, Malignant Melanoma, Hematological Malignancies, Myelogenous Leukemia, Chronic, Leukemia, Lymphoblastic, Acute
Intervention / Treatment:
PROCEDURE: Immunoablative Hematopoietic PBSC Transplant, PROCEDURE: Busulfan pharmacokinetics, RADIATION: Central Nervous System (CNS) prophylaxis radiation
| Inclusion Criteria:
* Patients with recurrent solid tumors
* Patients with malignant melanoma
* Patients with hematological malignancies.
* Chronic myelogenous leukemia in chronic or accelerated phase, to include chronic myelomonocytic leukemia (juvenile chronic myelogenous leukemia (JCML) or CMML).
* Acute lymphoblastic leukemia (ALL)
* First remission high-risk ALL (Ph+ with initial high white blood cell (WBC)t (4-11) in infants less than 1 year and CALLA negative)
* Second or subsequent remission ALL or isolated extramedullary disease on or off therapy.
* Acute non-lymphocytic leukemia (ANLL)
* Patients with ANLL in first remission who have a matched sibling donor.
* ANLL in second remission, or patients who only achieve an initial partial remission < 15% blasts, or early relapse.
* Myelodysplastic syndromes (MDS): refractory anemia (RA), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T) and CMML/JCML.
* Selected immunodeficiencies:
* Wiskott-Aldrich syndrome.
* Severe combined immunodeficiency variants that require ablation.
* Hyper-Immunoglobulin M (IgM) syndrome.
* Other immune deficiencies after approval from the medical director.
* Bone marrow failure syndromes (single or multiple hematopoietic lines)
* Venous access: A double lumen central vascular access device or its equivalent will be required for all patients entered on the protocol.
* Informed consent: The donor and the patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policy approved by the United States (U.S.) Department of Health and Human Services.
* Patient organ function requirements:
* Adequate renal function: serum creatinine < 2 x normal, or creatinine clearance calculated by Schwartz formula, of glomerular filtration rate (GFR) > 40 ml/min/1.73m2, or an equivalent GFR as determined by the institutional normal range.
* Adequate liver function: total bilirubin <= 2 x normal; and Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) <= 4 x normal.
* Adequate cardiac function: shortening fraction of > 24% by echocardiogram, or ejection fraction of > 30% by radionuclide angiogram.
* Adequate pulmonary function: Diffusion Lung Capacity Carbon Monoxide (DLCO), Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) > 30% by pulmonary function test. For children who are uncooperative for pulmonary function tests and have no evidence of dyspnea at rest or exercise intolerance, pulse oximetry > 94% on room air is considered acceptable.
* Performance status: Lansky Score >= 60% for children <= 16 years of age; or Karnofsky > 60% status for those > 16 years of age.
Exclusion Criteria:
* Patients who are pregnant
* Inability to find a suitable donor for the patient
* Patient is HIV-positive
* Patient has active Hepatitis B
* Disease progression or relapse prior to HPC infusion | 7,204 |
Study Objectives
This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.
Conditions: Recurrent Head and Neck Carcinoma
Intervention / Treatment:
RADIATION: Brachytherapy, DRUG: Cesium-131, PROCEDURE: Conventional surgery
| Inclusion Criteria:
* Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer* Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively* Age: Subjects must be ≥ 18 years of age and ≤ 90 years old* Informed Consent: All subjects must be able to comprehend and sign a written informed consent document
Exclusion Criteria:
* Subjects who are pregnant or may become pregnant* Unresectable tumor* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study | 11,693 |
Study Objectives
Investigators will test an evidence-based behavioral intervention that is responsive to Young Adults (YA's) expressed needs and priorities
Conditions: Cancer Survivor, Young Adult
Intervention / Treatment:
BEHAVIORAL: Cognitive-Behavioral Stress Management and Health Education
| Inclusion Criteria:
* 18-39 years old
* Diagnosed with cancer between 18-39 years old
* Cancer diagnosis was non-metastatic
* Completed cancer treatment between 1 month and 5 years prior to enrollment, with the exception of ongoing hormone therapy
* No documented or observable psychiatric or neurological disorders that could interfere with participation (e.g., active psychosis, active substance abuse), as identified by the referring medical team, chart review, or screening
* Able to speak and read English
* Able to provide informed consent
Exclusion Criteria:
* Metastatic disease
* Continued cancer treatment
* Psychiatric or neurological disorders that could interfere with study participation
* Vulnerable populations will not be included | 27,910 |
Study Objectives
The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.
Conditions: Gastric Cancer, Effects of Chemotherapy, Surgery
Intervention / Treatment:
| Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
* Age ≥18 years old
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Body mass index ≥ 18
* No prior chemotherapy or chemoradiotherapy
* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
* No evidence of metastasis (M0)
* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
Exclusion Criteria:
* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
* Patients with evidence of severe or uncontrolled systemic disease
* Medically unfit for chemotherapy | 18,345 |
Study Objectives
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy
Conditions: Bladder Cancer
Intervention / Treatment:
BIOLOGICAL: Vicinium
| Inclusion Criteria:
* Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows:
1. CIS (with or without papillary disease) OR
2. Any grade T1 papillary disease OR
3. High-grade Ta papillary disease based on a biopsy within 8 weeks of the initial dose of study treatment. If multiple bladder biopsies are required to confirm eligibility, the last bladder biopsy to the initial dose of study treatment must be within 8 weeks. This diagnosis must be confirmed by the independent central pathology reviewer prior to subject enrollment. A subject with persistent T1 disease on the second (i.e., restaging) TURBT may be enrolled in this study only if the investigator documents the subject declines cystectomy.* Subjects must have received adequate BCG treatment defined as at least 2 courses of BCG, i.e., at least one induction and one maintenance course or at least 2 induction courses. The initial induction course must be at least 5 treatments within a 7-week period. The second course (induction or maintenance) must be at least 2 treatments within a 6-week period. The "5+2" doses of BCG must be given within approximately 1 year (i.e., the start of one course to start of the second course within 12 months ±1 month) and for the same disease episode for which the subject is enrolling. Treatment must be considered "full-dose" BCG (see Section 10). If additional doses or courses of BCG above the minimum "5+2" are given, these do not have to be within the same approximate 12 month timeframe.
Subjects who were unable to receive at least 5 doses of BCG in a first course and at least 2 doses of BCG in a second course due to intolerance are not eligible.
Subjects who began their initial course of BCG with "full-dose" BCG and required dose-reductions due to adverse events but are still able to tolerate at least "5+2" doses of BCG are considered to meet the requirement for "adequate BCG." Subjects who received less than "full dose" BCG (e.g., 1/3rd dosing) as a standard regimen and not due to dose reductions because of AEs are not eligible.
The BCG may have been given in combination with interferon. When BCG is given simultaneously in combination with interferon, 1/3rd dosing of BCG is acceptable.* The subject's disease is refractory or has relapsed following adequate BCG treatment. Refractory disease is defined as disease which persists at the first evaluation following adequate BCG. Relapsed disease is defined as having a complete response to adequate BCG but recurs at a subsequent evaluation.
Subjects will enroll into one of three cohorts based on their type of disease and the time to refractory/relapsed disease following their last dose of BCG as follows:
* Cohort 1: Subjects with CIS with or without associated papillary disease whose disease is determined to be refractory or relapsed within 6 months of the last dose of adequate BCG treatment.
* Cohort 2: Subjects with CIS with or without associated papillary disease whose disease is determined to be refractory or relapsed more than 6 months but within 11 months of the last dose of adequate BCG treatment.
* Cohort 3: Subjects with high-grade Ta or any grade T1 papillary disease (without CIS) whose disease is determined to be refractory or relapsed within 6 months of the last dose of adequate BCG treatment.
For eligibility and cohort assignment, 6 months is defined as 30 weeks i.e., 26 weeks (6 months) plus an additional 4 weeks to accommodate scheduling variations and for diagnostic work-up and 11 months is defined as 50 weeks i.e., 48 weeks (11 months) plus an additional 2 weeks to accommodate scheduling variations and for diagnostic work-up.
For subjects enrolling in Cohort 2: The investigator documents he/she would not treat the subject with additional BCG at the time of study entry.* Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent.* All women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of the first dose of study therapy. A woman is not of childbearing potential if she has undergone surgical sterilization (bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy) or if she is ≥55 years of age and has had no menstrual bleeding of any kind including menstrual period, irregular bleeding, spotting, etc., for at least 12 months and there is no other cause of amenorrhea (e.g., hormonal therapy, prior chemotherapy).* All sexually active subjects agree to use barrier contraception (i.e., condoms) while receiving study treatment and for 120 days following their last dose of study treatment. WOCBP and males whose sexual partners are WOCBP agree to use barrier contraception and a second form of contraception while receiving study treatment and for 120 days following their last dose of study treatment.* Karnofsky performance status ≥ 60 (Appendix 1).* Adequate organ function, as defined by the following criteria:
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN);
* Total serum bilirubin ≤ 1.5 x ULN (CTCAE Grade ≤ 1);
* Serum creatinine ≤ 1.5 x ULN; or a creatinine clearance ≥40 mL/min;
* Hemoglobin ≥8.0 g/dL;
* Absolute neutrophil count ≥1500/mm3;
* Platelets ≥75,000/mm3* Ability to understand and sign an Independent Ethics Committee- or Institutional Review Board-approved informed consent document indicating that the subject (or legally acceptable representative) has been informed of all aspects of the trial and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. The informed consent document must be signed prior to the subject undergoing tests or procedures solely for determining study eligibility and prior to receiving any protocol treatment.
Exclusion Criteria:
* The subject is pregnant or breastfeeding.* Evidence of urethral or upper tract transitional cell carcinoma (TCC) within the past 2 years. Subjects with T1 disease must have no evidence of upper or lower tract disease or a more advanced stage of disease by CT urogram or MRI urogram of the abdomen and pelvis performed within 8 weeks of the first dose of study treatment. If intravenous contrast is contraindicated, retrograde ureteropyelography, or CT or MRI without intravenous contrast may be performed.* Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at Screening shows no evidence of tumor. Subjects with hydronephrosis that is unequivocally unrelated to upper tract malignancy may be considered eligible with Sponsor approval.* Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug.* History of recurrent severe urinary tract infections (UTIs) per investigator judgment. Subjects with a current UTI requiring antibiotic treatment may defer the initiation of Vicinium treatment on Day 1 until resolution of the UTI (even if this extends the screening period requirements to start of Vicinium treatment).* Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose the subject to the development of complications from the administration of intravesical therapy and/or general anesthesia.* The subject has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years i.e., while the subject may be taking study treatment. However, subjects with low-risk prostate cancer, e.g.:
* Clinically localized disease (≤T2a) and
* Gleason score 6 (3+3) and
* Serum PSA <10 ng/mL undergoing active surveillance may be enrolled with agreement of the sponsor.* A QTc interval of >470 msec by the Fridericia formula (QTcF), at the Screening ECG. If the subject's QTcF is >470 msec on the initial ECG, a total of 3 ECGs should be obtained at least 3 minutes apart and all within 30 minutes. The average of the 3 QTcF's will be used to determine eligibility. Known or suspected causes of prolonged QTc can be treated (e.g., hypocalcemia, hypokalemia, hypomagnesimia) and the ECGs may be repeated. If the subject initiates treatment with a drug known to prolong the QTc during the Screening period after the initial Screening ECGs were obtained, the Screening ECGs must be repeated once the new drug has reached steady state to ensure the average QTcF remains ≤470 msec. For subject's whose heart rate is <60 bpm, the Bazett correction formula (QTcB) may be used.* Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).* Local or severe allergy to any components of the drug regimen. | 19,048 |
Study Objectives
The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.
Conditions: Multiple Myeloma
Intervention / Treatment:
PROCEDURE: Autologous followed by non-myeloablative allogeneic transplantation
| Inclusion Criteria:a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol.
b) Age <= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation.
d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study.
e) Patients must have a Karnofsky performance status > 70%. f) DLCO >= 60% predicted. g) ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine < 2.0 or 24-hour creatinine clearance >= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent. Exclusion Criteria:a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study.
c) Patients who have an HLA-identical sibling donor will be excluded | 30,770 |
Study Objectives
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening mammography (XRM) are combined, compared to screening mammography alone in asymptomatic women with \>50% parenchymal density and a screening mammogram assigned a BI-RADS Assessment Category 1 (negative) or 2 (normal with benign findings).
The effect of the improved Reader performance is illustrated by plotting the ROC curves for XRM alone and XRM+ABUS. If Reader performance improves with the addition of ABUS to the XRM, the area under the curve (AUC) for XRM+ABUS (AUCXRM+ABUS) will be greater than the area under the curve for XRM Alone (AUCXRM Alone). This difference is represented as ∆AUCABUS. The null and alternative hypotheses can be formally expressed as follows:
H0: ∆AUCABUS = 0, AUCXRM+ABUS = AUCXRM Alone The null hypothesis is that Reader performance will be unchanged with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2.
HA: ∆AUCABUS ≠ 0, AUCXRM+ABUS ≠ AUCXRM Alone The alternative hypothesis is that Reader performance will be changed with the addition of ABUS to a screening mammogram assigned a BI-RADS Assessment Category of 1 or 2. A statistically significant change will be considered equivalent to a statistically significant improvement if the estimated value of AUCXRM+ABUS is greater than that of AUCXRM Alone with statistical significance at an alpha level of .05 for a two-sided test.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: Automated Breast Ultrasound (ABUS)
| Inclusion Criteria:
* Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
* Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
* Currently meets the minimum Mammography Interpretation requirements per MQSA
* Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
* Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
* Successful completion of ABUS training
Exclusion Criteria:
* Does not meet definition of Interpreting Physician as defined under 21CFR §900.12(a)(1)(i)(B)(2).
* Does not meet requirements of Fellowship-Trained in Breast Imaging and or have 10 years experience in breast imaging in which the radiologist's practice was at least 70% breast imaging
* Does not meet requirements of minimum Mammography Interpretation requirements per MQSA
* Does not meet requirements of Review Rate of at least 1,000 Mammograms annually for the year prior to study participation
* Does not meet requirements of Review Rate of at least 500 Breast Ultrasounds annually for the year prior to study participation
* Does not meet requirements of successful completion of ABUS training | 35,236 |
Study Objectives
This is a phase IIa, double-blind, randomised, placebo-controlled, multi-center study to evaluate the effects of estetrol on testosterone suppression and quality of life in prostate cancer patients treated with an LHRH agonist. Patients will be treated with estetrol or placebo for 6 months.
Conditions: Prostatic Neoplasm
Intervention / Treatment:
DRUG: Estetrol, DRUG: Placebo Oral Tablet
| Inclusion Criteria:
* Male patients with prostate cancer, qualifying for treatment with a LHRH agonist;
* Age ≥ 18 years;
* Body mass index (BMI) between ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive);
* Reasonable physical and mental health as judged by the Investigator determined by physical examination, clinical laboratory assessments and vital signs;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
* Life expectancy of at least 2 years.
Exclusion Criteria:
* Current or prior (during the last 12 months) hormonal therapy, immunotherapy or chemotherapy for prostate cancer. Allowed are 14 days concomitant treatment with an anti-androgen to prevent the flare-up, radiotherapy and low dose radiation to prevent gynecomastia;
* History of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident. However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
* History of myocardial infarction or a coronary vascular procedure (e.g. percutaneous coronary intervention, coronary artery bypass graft). However, patients with such history using anticoagulants for ≥ 6 months are eligible for the study provided anticoagulant treatment is continued throughout the whole study;
* Patients who have unstable angina or clinical congestive heart failure;
* A defect in the blood coagulation system, assessed at screening: deficiencies in AT-III, protein C and protein S and elevated factor VIII;
* Mutation in coagulation factor II and/or positive for factor V Leiden, assessed at screening;
* Diabetes mellitus with poor glycaemic control in the past 6 months (haemoglobin A1c (HbA1c) above 7.5%);
* Known primary hyperlipidaemias (Fredrickson);
* Disturbance of liver function: cholestatic jaundice, a history of jaundice due to previous estrogen use, Rotor syndrome and Dubin-Johnson syndrome;
* Known porphyria;
* Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication. | 3,639 |
Study Objectives
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone (PomDex) in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in Phase 2a in participants with r/r MM.
Conditions: Relapsed/Refractory, Multiple Myeloma
Intervention / Treatment:
DRUG: Mezagitamab, DRUG: Pomalidomide, DRUG: Dexamethasone
| Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status of <=2.* Has received previous myeloma-specific therapy.* In the Combination Cohort (TAK-079-PomDex) only must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator and the Pomalyst product information.* Documentation of RRMM as defined by the International Myeloma Working Group (IMWG) criteria.* For Participants with MM, measurable disease defined as one of the following:
* Serum M-protein >=0.5 g/dL (>=5 gram per liter \[g/L\]).
* Urine M-protein >=200 mg/24 hours.
* In participants without measurable M-protein in serum protein electrophoresis (SPEP) or urine protein electrophoresis (UPEP), a serum FLC assay result with involved FLC level >=10 mg/dL (>=100 milligram per liter \[mg/L\]), provided serum FLC ratio is abnormal.* Prior therapy should meet all the following criteria:
Participants in the dose Escalation Cohort (escalation phase) and participants in the dose Confirmation Cohort;
* Should be previously treated with at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a steroid. Note: Participants who have had a previous autologous stem cell transplant will have additionally been exposed to an alkylating agent; however, participant who have not had a previous autologous stem cell transplant may not have been exposed to an alkylating agent per standard practice.
* Should be refractory or intolerant to at least 1 PI and at least 1 IMiD.
* Should either have received >= 3 prior lines of therapy or should have received at least 2 prior lines of therapy if one of those lines included a combination of PI and IMiD.
* In phase 1, previous exposure to an anti-CD38 agent, as a single agent or in combination, is allowed but is not required. (Participants in the dose Escalation Cohort).
* In phase 1 dose Confirmation Cohort, cohorts of participants that are refractory at any time to at least 1 anti-CD38 agent or who are anti-CD38 naïve will be enrolled.
Participants in the Combination Cohort (TAK-079 added to PomDex cohort only):
* Have undergone prior therapy with >=2 prior anti-myeloma therapies (line of therapy defined below).
* Has either relapsed or relapsed and refractory disease. Should have progressed on or within 60 days of completing the last anti-myeloma therapy (refractory defined below).* In the phase 2a portion of the study, up to 2 cohorts of participants with RRMM may be enrolled: 1 that is refractory to at least 1 anti-CD38 monoclonal antibody (mAb) therapy at any time during treatment and 1 that is naïve to daratumumab.
Note:
o Refractory is defined as at least a 25% increase in M-protein (response of stable disease during prior therapy) or PD during treatment or within 60 days after last dose of prior therapy.
Exclusion Criteria:
* Sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade >=3.* Have received allogeneic stem cell transplant.* Have received anti-CD38 antibody therapy and do not fulfill a 180-day washout period before receiving TAK-079.* Not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline, excluding alopecia.* Clinical signs of central nervous system (CNS) involvement of MM.* Active chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, active HIV, or cytomegalovirus (CMV) infection.* POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, or IgM myeloma.* Positive Coombs tests at screening.* For participants in the Combination Cohort (TAK-079-PomDex) only: participant has previously received pomalidomide or has hypersensitivity to thalidomide or lenalidomide. | 6,502 |
Study Objectives
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
Conditions: Rectal Cancer
Intervention / Treatment:
DRUG: Capecitabine, DRUG: Oxaliplatin
| Inclusion Criteria:
* Age: 18 - 80
* Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
* According to MRI tumor extensions into the perirectal fat tissue (cT3)
* No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
* WHO performance status 0 - 2
* Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml)
* Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
* Adequate renal function (creatinin - not more than 1.5 mg/dl)
* Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
* Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study
* Life expectancy of at least 3 month
* Signed written Informed Consent before recruitment
* Exclusion of distant metastases at the time of recruitment
Exclusion Criteria:
* Former radio- and/or chemotherapy
* Tumor of the upper rectum
* Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
* Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
* General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
* Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders
* Florid, serious infection at the time of recruitment
* Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance
* Evidence of lacking willingness for cooperation of the patient
* Pregnant or breast feeding women | 20,780 |
Study Objectives
The objectives of this study are to develop a Culturally Tailored Genetic (CTGC) protocol for African American women and evaluate its impact on decision making and satisfaction about BRCA1/2 testing, quality of life, and cancer control practices compared to Standard Genetic Counseling (SGC). A secondary objective of this study is to identify African American women who are most and least likely to benefit from CTGC vs. SGC.
Conditions: Breast Cancer, Ovarian Cancer
Intervention / Treatment:
BEHAVIORAL: Culturally Tailored Genetic Counseling
| Inclusion Criteria:
* Female
* African American or Black
* 5% to 10% prior probability of having a BRCA1 or BRCA2 mutation
Exclusion Criteria:
* Men
* Individuals who are not African American or Black | 13,609 |
Study Objectives
Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.
Conditions: Rectal Cancer
Intervention / Treatment:
OTHER: Procedure/Surgery
| Inclusion Criteria:
* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* Undergoing transanal total mesorectal excision
Exclusion Criteria:
* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure | 38,495 |
Study Objectives
Patients with Parkinson's disease will be seen by a dermatologist who will biopsy any suspicious skin lesions.
Conditions: Parkinson's Disease, Malignant Melanoma
Intervention / Treatment:
| Inclusion Criteria:
Confirmed diagnosis Parkinson's disease Patient able and willing to give informed consent Patient must not be taking any investigational drug at the time of enrollment
Exclusion Criteria:
unconfirmed, undocumented Parkinson's disease unable to give consent taking any investigational product | 8,707 |
Study Objectives
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.
Conditions: Rectal Cancer
Intervention / Treatment:
DEVICE: Micro Hand S robot and da Vinci robot, DEVICE: da Vinci robot
| Inclusion Criteria:
* histologically confirmed rectal cancer; ASA score ≤ 3
Exclusion Criteria:
* palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery | 15,676 |
Study Objectives
This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Intervention / Treatment:
| Inclusion Criteria:
* Adult patients, >=18 years of age
* Diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC, stage III/IV)
* Treatment with Tarceva monotherapy and not progressing after at least 9 months at the date of study start
Exclusion Criteria:
* Not agreeing to be followed-up (for a maximum of 24 months) | 17,896 |
Study Objectives
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
Conditions: Pancreatic Neuroendocrine Tumors
Intervention / Treatment:
DRUG: everolimus
| Inclusion Criteria:
* Patients must have histological confirmed G1 or G2 pancreatic neuroendocrine tumors(pNETs) (WHO 2010)
* Patients must have radiological documentation of progression of disease per RECIST 1.1 within 12 months prior to enrollment.
* Measurable disease per RECIST 1.1 criteria using triphasic computed tomography (CT) scan or multiphase MRI for radiologic assessment.
* everolimus treatment which is recommended by the treating physician
Exclusion Criteria:
* Hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.
* Patient who is unwilling to receive Afinitor treatment due to any reason.
* Pregnant or nursing (lactating) women,
* Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
* Use of an investigational drug within the 30 days prior to enrollment | 33,326 |
Study Objectives
Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC.
However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Intervention / Treatment:
OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics
| Inclusion Criteria:
* Participants aged above 18 years.* Patients who signed informed consent.* PDAC patients diagnosed via postoperative pathology.
Exclusion Criteria:
* Comorbidity with other cancers.* Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.* Use of antibiotics, probiotics or prebiotics in the previous month. | 31,208 |
Study Objectives
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.
Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.
This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.
Conditions: Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Cisplatin, DRUG: Sorafenib
| Inclusion Criteria:
* Histologically / cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma. Combined cholangiocarcinoma and hepatocellular carcinoma is allowed.Patients must have uni-dimensionally measurable disease by x-ray, CT scan, MRI scan or physical examination.
* KPS ≥ 80%
* Age ≥ 18 years
* Adequate bone marrow function defined as: Hb ≥ 8 g/dl, ANC ≥ 1.5 K/mcL, Platelets ≥ 100 K/mcL
* Adequate renal function defined as Serum creatinine < 2.0 mg/dl and calculated creatinine clearance ≥ 60 ml/min using the formula:
* Cockcroft-Gault formula:
Cockcroft-Gault Formula - MALES CrCl = (140 - age\[years\]) (body wt\[kg\]) (72) (serum creatinine \[mg/dL\]) Cockcroft-Gault Formula - FEMALES CrCl = 0.85 x male value
* If calculated creatinine clearance is not within range using the above formula, then measured levels from 24-hour urine collection may be used to calculate the creatinine clearance.
* Adequate hepatic function defined as total bilirubin ≤ 2 mg/dl, ALT/AST/ ≤ 3 x ULN (≤ 5 if liver metastases). Patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage.
* PT/INR ≤ 1.7 and PTT ≤ 1.5 x ULN, unless the patient is receiving anti-coagulation therapy with agents such as warfarin or heparin
* Patients who have received prior local therapy, i.e. embolization, radiation therapy, etc. (except for chemoembolization) are eligible provided that measurable disease falls outside the treatment field or within the field but has shown an increase of ≥20% in the size. Prior local therapy must be completed at least 4 weeks prior to the baseline scan
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Patients are encouraged to continue barrier method contraception for two years or longer after treatment.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Any previous chemotherapy, biologic therapy, or investigational agent, except for 5-FU or gemcitabine given as adjuvant therapy as single agents and/or as radio-sensitizing agents. Patient must have completed adjuvant therapy no less than six months prior to accrual. Patients with previous significant allergic hypersensitivity to gemcitabine are excluded.
* Evidence of another active cancer that may influence patient outcome as determined by the Principal Investigator, except for non-melanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix curatively treated, treated superficial bladder cancer, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable.
* Known brain metastases
* History of primary central nervous system tumors or brain metastases, and/or seizures not well controlled with standard medical therapy.
* Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements.
* Known HIV positive patient
* Blood Pressure of > 150/100 mm Hg
* Significant cardiovascular disease including congestive heart failure (New York Heart Association Class II or higher) or active angina pectoris.
* History of a myocardial infarction within 6 months.
* History of a stroke or transient ischemic attack within 6 months.
* Clinically significant peripheral vascular disease.
* Evidence of bleeding diathesis or coagulopathy.
* Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks.
* Uncontrolled infection.
* Known or suspected allergy to sorafenib or any agent given in the course of this trial.
* Pregnant (positive pregnancy test)
* Breast-feeding should be discontinued if the mother is to be treated on clinical trial.
* Serious non-healing wound, ulcer, or bone fracture
* Use of St. John's Wort or rifampin (rifampicin)
* Any condition that impairs patient's ability to swallow whole pills
* Any malabsorption problem | 30,201 |
Study Objectives
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Conditions: Healthy Volunteer
Intervention / Treatment:
DRUG: DMB-3111, DRUG: trastuzumab
| Inclusion Criteria:
* Healthy Japanese male adults* Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/\[Height (m)\]²* The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.
Exclusion Criteria:
* History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug* Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)* History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators* History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia | 20,087 |
Study Objectives
The primary objective of the present study is to investigate the influence of co-administration of itraconazole and volasertib on the pharmacokinetic profile of volasertib without co-administration of itraconazole. Secondary objectives are to investigate safety, tolerability and preliminary therapeutic effects following intravenous administration of volasertib.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: volasertib, DRUG: itraconazole
| Inclusion criteria:
* Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour, for whom conventional treatment has failed, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment based on the investigator's assessment* Male or female* Age =>18 and =<70 years* Eastern Cooperative Oncology Group (ECOG) performance score =< 2* Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade >= 2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy (except alopecia)
Exclusion criteria:
* Serious concomitant non-oncological disease considered by the investigator to be incompatible with the protocol* Active infectious disease* Viral hepatitis, HIV infection* Clinical evidence of active brain metastasis or leptomeningeal disease during the past 6 months* Second malignancy currently requiring active therapy (except for hormonal / antihormonal treatment e.g. in prostate or breast cancer)* Absolute neutrophil count less than 1,500/mm3* Platelet count less than 100,000/mm3* Total bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)* Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)* Serum creatinine greater than 2x upper limit of normal (ULN)* QTcF prolongation > 470 ms or QT prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).The QTcF will be calculated as the mean of the 3 ECGs taken at screening* Female patients with childbearing potential and unwilling to use a medically acceptable method of contraception during the trial and for at least six months after end of active therapy. Woman of childbearing potential (premenopausal female) is defined as the female who is not surgically sterilised by hysterectomy or bilateral tubal ligation or post-menopausal for at least 12 months.* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks prior to start of therapy or concomitantly with this trial* Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of therapy or concomitantly with this trial. This restriction does not apply to steroids, bisphosphonates hormonal / antihormonal treatment (e.g. in prostate or breast cancer).* Alcohol abuse more than an average 3 units of alcoholic beverages per day or more than 21 units per week (1 unit equals 0.5 pint \[285 mL\] of beer or lager, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) or drug abuse* Life expectancy less than 12 weeks* Potent CYP 3A4 and P-glycoprotein inhibitors other than the study drug or inducers between one week prior to first drug administration or expected treatment with a respective drug until the last PK sample is collected
1. Strong CYP 3A4 inhibitors: atazanavir, clarithromycin, indinavir, itraconazole (other then study drug), ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin
2. CYP 3A4 inducers: carbamazepine, rifampicin
3. P-gp inhibitors: cyclosporine, erythromycin, itraconazole (other then study drug), ketoconazole, quinidine, phenobarbital salt with quinidine, ritonavir, valspodar, verapamil
4. P-gp inducers: hypericum perforatum, rifampicin | 26,259 |
Study Objectives
Cancer survivors face unique health challenges as a result of their cancer diagnosis and treatment. OncoLink created an Internet based program for survivors to learn about their risks. A follow up survey will allow us to continue to develop the program in ways that will benefit users. This survey will need to be conducted via email, which will require the collection of the users email address and a secure method of linking the users care plan questionnaire answers to their survey answers.
Conditions: Cancer Patient
Intervention / Treatment:
OTHER: Survey
| Inclusion Criteria:
* Diagnosis of cancer
* 18 years of age and older
Exclusion Criteria:
* Persons who have never had cancer. This program is designed for survivors of adult cancers.
* Survivors of childhood cancers are referred to the Children's Oncology Group Long Term Follow up Guidelines. | 10,648 |
Study Objectives
This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.
Conditions: Sleep Disorder, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Brief Behavioral Therapy, BEHAVIORAL: Telephone-Based Intervention, OTHER: Educational Intervention, BEHAVIORAL: Telephone-Based Intervention
| Inclusion Criteria:
* Newly diagnosed breast cancer (stage I, II, III)
* Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (Note: use of biologics \[e.g., Herceptin (trastuzumab)\] is permitted)
* For patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining
* For patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining
* Patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
* Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia Severity Index
* (Note: this measure will be repeated again at baseline assessment)
* Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
* Be able to speak and read English
* Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
* Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are scheduled to wear it
Exclusion Criteria:
* Have diagnosis of breast cancer stage IV
* Have sleep problems that began before diagnosis and have not changed since diagnosis
* Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
* Have a clinical diagnosis of sleep apnea or restless leg syndrome
* Be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions
* Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
* Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
* Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.) | 21,124 |
Study Objectives
This non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' HRQoL. In addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of Greek subjects with aSTS.
Conditions: Advanced Soft Tissue Sarcoma
Intervention / Treatment:
| Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
* Adult outpatients (18 years and older) of either gender;
* Patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs;
* Patients for whom the decision to prescribe therapy with trabectedin (Yondelis®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study;
* Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
* Patients must have signed an informed consent document;
* Patients must be able to read, understand and complete the study specific questionnaires.
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
* Patients who have received more than one cycle of trabectedin at the time of enrolment into the study;
* Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
* Patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin. | 14,137 |
Study Objectives
The purpose of this study is to determine whether or not there are more complications in the extraperitoneal compared with the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer
Conditions: Endometrial Neoplasms, Ovarian Neoplasms
Intervention / Treatment:
PROCEDURE: Extraperitoneal Laparoscopic aortic lymphadenectomy, PROCEDURE: Transperitoneal Laparoscopic aortic lymphadenectomy
| Inclusion Criteria:
* Diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to FIGO (the International Federation of Gynecology and Obstetrics) recommendations
* Diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to FIGO recommendations
Exclusion Criteria:
* Diagnosis of advanced endometrial cancer based on findings on imaging techniques (CT, MRI and/or PET)
* Diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy)
* Patients who underwent previous aortic lymphadenectomy
* Patients who received previous pelvic and/or aortic radiotherapy | 14,446 |
Study Objectives
This study is an extension study to the Callisto protocol CP-106. Subjects must have completed all 12 treatment cycles of CP-106 without disease progression as per RECIST criteria,to be eligible to to be enrolled in this study. This study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).
Conditions: Neuroendocrine Carcinoma
Intervention / Treatment:
DRUG: Atiprimod
| Inclusion Criteria:
* Subject was enrolled in Protocol No. CP-106 and successfully completed 12 treatment cycles.* Subject must have been classified as a responder at the time of completion of Protocol No. CP-106 \[i.e., SD or better per RECIST Committee criteria or stable symptoms or better (defined as an average daily frequency of bowel movements, flushing episodes and/or wheezing episodes that is the same as or less than the average daily frequency of bowel movements, flushing episodes and/or wheezing episodes recorded during the 14-day screening period prior to enrollment in Protocol No. CP-106)\].* Subject must understand and voluntarily sign the informed consent document.* Subject must have adequate organ function defined as follows: Absolute granulocyte count (AGC) >1,500/mm3, hemoglobin >8 g/dl, platelets >100,000/mm3, serum bilirubin <1.5 x upper limit of normal (ULN), serum creatinine <1.5 mg/dL, SGOT ≤Grade 1 per NCI CTCAE, SGPT ≤Grade 1 per NCI CTCAE.* Women of child bearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).
Exclusion Criteria:
* Subject who was enrolled in Protocol No. CP-106 and who did not successfully complete 12 treatment cycles.* If WCBP, pregnant, lactating or not using adequate contraception.* Clinically relevant active infection or serious co-morbid medical conditions that are uncontrolled or whose control may be jeopardized by atiprimod treatment.* Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol.* Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.* As atiprimod is a potent inhibitor of CYP2D6, the use of drugs that are substrates of CYP2D6 (e.g. beta blockers, antidepressants, and antipsychotic;) will not be allowed while on study. | 575 |
Study Objectives
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".
Conditions: Pathological Response Rate
Intervention / Treatment:
DRUG: vectibix, DRUG: fluorouracile, DRUG: Epirubicine, DRUG: cyclophosphamide, DRUG: docetaxel
| Inclusion Criteria:
* Age ³ 18.- Performance status £ 2 (according to WHO criteria).
* Patient has histologically confirmed, non-metastatic breast cancer, with a clinical tumour diameter of ³ 2 cm
* HR negative and Her-2 negative.
* Clinical stage II and IIIa.
* Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy.· Haematology: o Neutrophil count ≥1.5x109/Lo Platelet count ≥100x109/Lo Leucocyte count > 3,000/mmo Hb> 9g/dl· Hepatic Function:o Total bilirubin ≤ 1.5 time the upper normal limit (UNL)o ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases Alkaline phosphatase ≤ 2.5 time the upper normal limit (UNL)· Renal Function· Creatinine clearance ≥50 mL/min and serum creatinine ≤1.5xUNL· Metabolic Function o Magnesium ≥ lower limit of normal. o Calcium ≥ lower limit of normal.
* Patient with no progressive heart disease, and for whom anthracyclines are not contraindicated (normal FEV).
* Patient has signed the consent forms for participation before inclusion in the trial.
* Member of a Social Security scheme (or a beneficiary of such a scheme) according to the provisions of the law of 9 August 2004.
Exclusion Criteria:
* Male patients.
* Her-2 positive patients
* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
* Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
* Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d).
* Non-measurable tumour.
* Patients have already undergone surgery for their disease or have had primary axillary dissection.
* Patient has already been treated for new breast cancer.
* Patient is a ward.
* Patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured.
* Patient has another disease which is deemed incompatible with the patient being included in the protocol.
* Heart or kidney failure, medullary, respiratory or liver failure.
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) £ 1 year before enrollment/randomization
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
* Significant neurological or psychiatric abnormalities.
* Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis at the initial check-up.
* Peripheral neuropathy > grade 2 (NCI-CTCAE criteria, Version 3.0).
* History of allergy to polysorbate 80.
* Concomitant treatment with a trial drug, participation in another clinical trial within < 30 days or previous chemotherapy.
* Patient with no fixed address in the next 6 months or living at a distance from the treatment centre so it is difficult to check her progress.
* Prior anti-EGFr antibody therapy (e.g.:cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib).
* Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
* Any investigational agent within 30 days before initiation of study treatment. - Must not have had a major surgical procedure within 28 days of initiation of treatment.
* Subject unwilling or unable to comply with study requirements. | 20,257 |
Study Objectives
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and vital blue dye.
Conditions: Breast Cancer, Melanoma
Intervention / Treatment:
DRUG: Lymphoseek
| Inclusion Criteria:
* The patient has provided written informed consent with HIPAA authorization.* The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.* The patient is at least 18 years of age at the time of consent.* The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).* The patient has a clinical negative node status at the time of study entry (i.e. T0-4, N0, M0, see Appendix D and E).* If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
Melanoma Patients* The patient has a diagnosis of primary melanoma. Breast Cancer Patients* The patient has a diagnosis of primary breast cancer.* Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.
Exclusion Criteria:
* The patient is pregnant or lactating.* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0, see Appendix D and E).* The patient has a known hypersensitivity to Lymphazurin.* The patient has participated in another investigational drug study within 30 days of scheduled surgery.
Melanoma Patients* The patient has a tumor with a Breslow depth less than 0.75mm.* Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.* Patient has been diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin.* Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.* Patient has undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap, or skin graft of any type).
Breast Cancer Patients* The patient has bilateral primary breast cancers or multiple tumors within their breast.* Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.* Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.* Patient has had preoperative radiation therapy to the affected breast or axilla. | 4,189 |
Study Objectives
Epidural analgesia is considered by many to be the reference standard which has been shown to reduce the intraoperative surgical stress response.
However, besides its excellent analgesic effect, there are some disadvantages associated with epidural analgesia. This includes the risk of epidural hematoma/abscess ,failure rates hypotension, urinary retention. Also the need for preoperative placement in awake patients, who seem to dislike and sometimes even refuse. It is contra-indicated in the presence of coagulopathy or local sepsis.
ESPB is a faster procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, easy to perform, and requires less training.
So this study is to compare the postoperative analgesic effect of continous bupivacaine infusion via thoracic epidural versus erector spinae catheters following upper abdominal cancer surgery.
Conditions: Pain Relief in Upper Abdominal Cancer Surgeries
Intervention / Treatment:
PROCEDURE: erector spinae block
| Inclusion Criteria:
* Patients subjected to major upper abdominal cancer surgery.
* The enrolled age will be from 18 years to 70 years
* ASA I-II and NYHA I-II.
Exclusion Criteria:
* ASA physical status >II, and NYHA >II
* Patient refusal
* body mass index >40 kg/m2
* preoperative opioid consumption
* a local infection at the incision site
* a history of hematological disorders or coagulation abnormality
* previous abdominal surgeries, severe hepatic or renal impairment
* Anomalies of vertebral column.
* Pregnant women
* Hypersensitivity to any of used drugs
* chronic pain | 35,413 |
Study Objectives
patients om metformin from diabetic clinic were checked for bladder cancer
Conditions: Bladder Cancer, Diabetes
Intervention / Treatment:
OTHER: metformin
| Inclusion Criteria:
* 150 people attending diabetic clinic
Exclusion Criteria: | 25,575 |