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Study Objectives
The purpose of this study is:
1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during induction and consolidation courses versus no priming.
2. To compare as consolidation timed sequential chemotherapy versus four courses of high dose cytarabine.
Conditions: Acute Myeloid Leukemia
Intervention / Treatment:
DRUG: GM-CSF
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* A morphologically proven diagnosis of AML according to the WHO classification
* Serum creatinine \< 2N; AST and ALT \< 2.5N; total bilirubin \< 2N (unless related to the underlying disease).
* ECOG performance status 0 to 2.
* Women of child-bearing must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
* Must be able and willing to give written informed consent
Exclusion Criteria:
* Patients with M3-AML. Patient with AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).
* Patient presenting any diagnosis of uncontrolled or metastatic tumor.
* Patients with uncontrolled severe infection, | 14,228 |
Study Objectives
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with stereotactic body radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic body radiation therapy works in treating patients with locally advanced or metastatic non-small cell lung cancer.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: Erlotinib, RADIATION: SBRT
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
1. Patients must have biopsy proven NSCLC that is locally advanced or metastatic.
2. Patients must have had failure of at least one prior chemotherapy regimen.
3. Patients must not have started erlotinib therapy more than 4 weeks prior to the initiation of SBRT.
4. Age ≥ 18 years
5. Patients must have measurable disease at baseline.
6. Patients can have up to only 6 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by PET scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of SBRT.
1. For patients who have received prior radiotherapy to the primary site in the lung, residual PET activity is difficult to interpret and will not be considered a site of active disease if the CT appearance is stable or improved over an interval of at least three months
2. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
3. Patients with previously un-irradiated primary sites will be potentially eligible, but special considerations apply (section 4.3.2).
4. Up to 2 contiguous vertebral metastases will be considered a single site of disease.
7. Patients must have a KPS \>60
8. AST, ALT \& Alkaline phosphates must be ≤ 2.5X the upper limit of normal. Total bilirubin must be within the limit of normal.
9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
11. Females of childbearing potential should have a negative pregnancy test.
12. Patients who would be receiving SBRT for lung tumors who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1L.
13. Patients must provide verbal and written informed consent to participate in the study.
14. Total bilirubin: within normal institutional limits
Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
1. Patients who previously received radiotherapy to the primary site with CT evidence of disease progression at the primary site within 3 months following the initial radiotherapy.
2. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
3. Patients with serious, uncontrolled, concurrent infection(s).
4. Significant weight loss (\>10%) in the prior 3 months.
5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
6. Patients with cutaneous metastasis of NSCLC.
7. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
8. Patients with more than 6 discrete extra-cranial lesions.
9. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
10. Unwillingness to participate or inability to comply with the protocol for the duration of the study.
11. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study.
12. Patients who have had prior EGFR inhibitors. | 43,930 |
Study Objectives
This phase II trial studies how well physical activity monitored by Fitbit Charge 2 works in improving quality of life in participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back. A modern, state of the art activity tracking device (Fitbit Charge 2) may help to measure physical activity, heart rate, and sleep pattern, and may help doctors to learn whether physical activity level has any relationship to energy level, sleep duration and quality, toxicity from chemotherapy, immune cells in blood, and bacterial composition in gut.
Conditions: Fallopian Tube Endometrioid Tumor, Fallopian Tube Mucinous Neoplasm, Fallopian Tube Serous Neoplasm, Ovarian Clear Cell Tumor, Ovarian Endometrioid Tumor, Ovarian Mucinous Tumor, Ovarian Serous Tumor, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DEVICE: Monitoring Device, OTHER: Physical Activity, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1
* Have recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer (serous, clear cell, endometrioid or mucinous)
* Patient is willing to wear activity tracking device at least 70% of the time for the duration of the study (9 months)
* Patient is getting cancer treatment and surveillance visit at Roswell Park Cancer Institute during the study period
* Patient is willing to participate in quality of life (QOL) questionnaires and blood and stool collection throughout the study for translational research purposes
* Has no risk factors for increased risk for exercise related complications assessed by 2017 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) questionnaire and principal investigator (PI)/cooperative (Co)-PI
* If positive screening test on 2017 PAR-Q+ questionnaire, medical clearance need to be documented by PI/Co-PI with doctor of medicine (MD) degree and/or primary care physician or cardiologist, if deemed necessary by the PI/Co-PIs prior to starting increased physical activity (PA) portion of the trial
Exclusion Criteria:
* Patient with serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization in the previous 12 months)
* Patients with a life expectancy of less than 6 months
* Patients may not have any other active malignancy that currently requires treatment with the exception of non-melanoma skin cancer
* Unwilling or unable to follow protocol requirements | 6,052 |
Study Objectives
The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.
Conditions: Pre- and Postoperative Analgesia, Spinal Anesthesia, Renal Cell Carcinoma
Intervention / Treatment:
DRUG: klonidin, DRUG: epidural anesthesia
Location: Sweden
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma
Exclusion Criteria:
* patients in ASA score IV-V,
* patients with advanced tumour thrombus in vena cava inferior,
* patients with high risk for bleeding
* patients with previous chronic pain symptoms
* patients having drug abuse
* patients having cognitive deficiencies or dementia disease
* patients with any contraindication of either spinal or epidural anesthesia
* patients younger than 18 years and pregnant woman
* patients having a weight less than 45 kg or weight over 120 kg | 239 |
Study Objectives
This study aims to investigate mechanisms that dictate tumor immunogenicity and to explore potential biomarkers that could help predict changes of tumor immunogenicity and therapeutic response in patients with cervical cancer after chemoradiotherapy or surgery.
Conditions: Cervical Cancer, Benign Tumor of Uterus
Intervention / Treatment:
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Pathological proven diagnosis of cervical cancer or benign gynecologic tumor and will undergoing panhysterectomy or pathological proven diagnosis of cervical cancer and will undergoing radiotherapy
* Tumor accessible for biopsy during the course of radiotherapy or tumor samples could be obtained via surgery
* Patient must provide study-specific informed consent prior to study entry
Exclusion Criteria:
* History of autoimmune diseases
* History of immunotherapy
* History of pelvic radiotherapy
* Will receive immunotherapy during the course of treatment
* Contraindications for biopsy, such as high bleeding risk | 616 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of sequential chemotherapy followed by peripheral stem cell transplantation in treating patients with persistent or platinum refractory stage III or stage IV ovarian cancer.
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: endocrine-modulating drug therapy, DRUG: melphalan, DRUG: mitoxantrone hydrochloride, DRUG: tamoxifen citrate, DRUG: thiotepa, PROCEDURE: peripheral blood stem cell transplantation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven persistent or platinum refractory stage III/IV ovarian cancer
PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/mL, unless history of Gilbert's disease SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine clearance at least 50 mg/mL No history of hemorrhagic cystitis Cardiovascular: No history of coronary artery disease No poorly controlled arrhythmia or myocardial infarction Left ventricle ejection fraction at least 50% Pulmonary: Diffusion capacity at least 50% Other: Not pregnant HIV negative No second malignancy in the last 5 years except basal carcinoma of the skin
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No history of allergy to any chemotherapy drugs Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified | 18,217 |
Study Objectives
A research study of a procedure to treating lung cancer with focused radiation called Stereotactic Ablative Radiotherapy (SABR). The purpose of this study is to evaluate the effectiveness of individualizing the dose of radiation used to treat lung tumors with SABR based on tumor-specific factors.
While recent research has identified SABR as a promising method to increase local control (LC) of lung cancer, further research has indicated that tumor volume is a prognostic factor, with increased size/volume of tumor being associated with poorer outcomes. This study explores if a volume-adapted strategy for the radiologic exposure (dose) will improve efficacy in larger tumors (ie, \> 10 cc).
This is a study of the procedure stereotactic ablative radiotherapy (SABR). It is not a study of a specific drug or device.
Conditions: Non-small Cell Lung Cancer (NSCLC)
Intervention / Treatment:
RADIATION: iSABR, 25 Gray in 1 fraction for small peripheral tumors, RADIATION: iSABR, 50 Gray in 4 fractions for medium peripheral tumors, RADIATION: iSABR, 54 Gray in 3 fractions for large peripheral tumors, RADIATION: iSABR, 40 Gray in 4 fractions for small central tumors, RADIATION: iSABR, 50 Gray in 4 fractions for medium central tumors, RADIATION: iSABR, 60 Gray in 8 fractions for large central tumors
Location: Canada, United States, Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | INCLUSION CRITERIA
* Limited primary non-small cell lung cancers (NSCLC) (ie, graded as T1aN0M0, T1bN0M0, T2aN0M0, T2bN0M0, or T3N0M0), or metastatic lung tumors with no evidence of uncontrolled extrathoracic metastases.
* Up to 4 lesions may be considered.
* For a single lesion, the sum of three orthogonal diameters can be no more than 20 cm.
* For multiple lesions, no lesion can have a sum of orthogonal diameters greater than 15 cm.
* Both peripheral and central tumors are accepted for this trial.
* Age ≥ 18 years old
* Patients may be enrolled more than once (eg, for a new tumor lesion)
EXCLUSION CRITERIA
* Contraindication for radiotherapy
* Pregnant and breastfeeding women are excluded
* If prior radiation therapy, there is no overlap with the prior high dose regions (EXCEPTION: by approval of the investigators). | 8,362 |
Study Objectives
The investigators research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.
Conditions: Colon Cancer, Lynch Syndrome
Intervention / Treatment:
PROCEDURE: MSI screening test
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. At least 18 years old
2. Kaiser Permanente member
3. Referral or scheduled colon surgery
4. No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the ability to be consented
5. English speaker
6. Diagnosis of colon cancer
Exclusion Criteria:
1. Under the age of 18
2. Known cognitive impairment
3. Inability to speak/understand English
4. On the research exclusion list
5. Known Lynch syndrome
6. No diagnosis of colon cancer
7. In hospice | 3,284 |
Study Objectives
Conjugated Linoleic Acid (CLA) is obtained in the human diet by consumption of foods containing ruminant fat. Milk and dairy products have shown the highest amounts of CLA. Clarinol (CLA), is considered a natural supplement and is not regulated by the Food and Drug Administration (FDA). CLA is known to inhibit proliferation of human breast cancer cells and tumors in rodent breast cancer models and reduced Spot 14 (THRSP, S14) and Fatty Acid Synthase (FASN) gene expression in breast cancer cells and tht the two major CLA isomers used in nutritional supplements (C9, t11 and t10, c12) were equipotent in reducing breast cancer cell growth. This study looks at the hypothesis that S14 expression is decreased by CLA and will characterize the major pharmacodynamic (PD) effects of CLA in newly diagnosed Breast cancer patients on Tumor tissue lipogenic pathway. FASN, S14 and Lipoprotein Lipase (LPL), Ki67 and apoptotic index expression will be assessed by quantitative immunohistochemistry (IHC) in initial breast cancer biopsies and compared to that in resected breast tumor tissue after the study subject has been taking CLA for ten to twenty-eight days. Tissue from adjacent breast adipocytes will also be analyzed to determine whether adipose tissue effects can serve as a surrogate marker for those in tumor tissue. A sample of the original biopsy will be compared to the tumor resection sample to determine the levels of CLA in the breast cancer cells.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Conjugated Linoleic Acid (CLA)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).
* All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
* All subjects must be Age \>18 years.
* All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT) ≤ 1.5 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤ 1.5 times the upper limit of normal or eCRCl ≥ 60 mL/min.
Exclusion criteria:
* Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.
* Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.
* Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.
* Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.
* A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded. | 20,640 |
Study Objectives
This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics \& Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.
The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):
1. Date of death - the date at which a patient was reported in the database as having died
2. Last month active - the last recorded mention of the patient in the dataset
3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.
Conditions: Neuroendocrine Tumor
Intervention / Treatment:
DRUG: Lutetium-177 DOTATATE
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion criteria
* Diagnosis of any NET
* Evidence of re-treatment with lutetium-177 DOTATATE
* Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 DOTATATE
* Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose
Exclusion criteria
• \<18 years of age | 3,638 |
Study Objectives
Ratiotherapy alone is the current standard treatment for elderly esophageal or esophagogastric cancer in China. And Little is known about chemoradiotherapy (CRT) in elderly patients. This study aimed to assess the efficiency and safety of simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) with S1 based SIB-IMRT followed by adjuvant chemotherapy with S1 in in elderly (age ≥70 years) esophageal or esophagogastric cancer patients
Conditions: Esophagus Cancer, Esophagogastric Junction Cancer, Radiotherapy; Complications, Chemoradiation
Intervention / Treatment:
RADIATION: SIB-IMRT, DRUG: S-1
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* ≥70 years
* Esophageal or Esophagogastric cancer
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent
Exclusion Criteria:
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* With esophageal fistula, perforation, cachexia prior to treatment
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Pregnant or lactating females | 20,680 |
Study Objectives
This trial is designed to determine the feasibility of conventional induction chemotherapy, IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.
Conditions: Leukemia
Intervention / Treatment:
DRUG: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
DLI Recipient
* Relapsed AML or ALL ≥ 60 days after allogeneic SCT.
* Evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
* Age ≥ 18 years of age,
* Karnofsky performance status ≥ 60%.
* Absence of active GVHD and off immunosuppression. Subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. We suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
* Adequate organ function: Cr ≤ 2 mg/dL; ALT/AST \< 3x ULN, direct bili \<3x ULN.
* Matched sibling or un-related donor (A, B, C, and DR) available to undergo leukopheresis.
* Subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
* Willing to provide blood samples for research purposes.
* Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility - tubal ligation or vasectomy in patient or partner, or oral contraceptive).
DLI Donor
1. HLA identical to recipient subject.
2. Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient's primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors).
3. Considered medically eligible to receive G-CSF (filgrastim) by independent donor physician.
Exclusion Criteria
Recipient
* Prior cell therapy for relapse within the past 90 days.
* Requirement for active immunosuppression to treat GVHD.
* Pregnant or lactating women. The safety of this therapy on unborn children and effects on breast milk are not known.
* Uncontrolled active infection
* Any uncontrolled active medical disorder that would preclude participation as outlined.
Donor
- Unable to participate in a leukopheresis procedure or receive G-CSF (filgrastim). | 33,428 |
Study Objectives
This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.
Conditions: Recurrent Aggressive Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent High Grade B-Cell Lymphoma, Recurrent Malignant Neoplasm, Recurrent Plasma Cell Myeloma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory Aggressive Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory High Grade B-Cell Lymphoma, Refractory Malignant Neoplasm, Refractory Plasma Cell Myeloma, Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
Intervention / Treatment:
DRUG: Fluorine F 18-fluoroazomycin Arabinoside, PROCEDURE: Positron Emission Tomography
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Histologically confirmed diagnosis of:
* Aggressive lymphoma, including: Diffuse large B-cell lymphoma (DLBCL) (including transformed disease), high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma
* Multiple myeloma (MM), with imaging within 6 months of enrollment demonstrating \>= 1 plasmacytoma measuring \>= 5 cm along any axis
* Other malignancy with radiographically measurable disease
* R/R disease with planned receipt of CAR T-cell therapy at University of California, San Francisco (UCSF), either through an Food and Drug Administration-approved CAR construct or through a separate interventional clinical trial
* Ability to provide informed consent prior to study entry
Exclusion Criteria:
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
* Pregnancy or active lactation | 13,810 |
Study Objectives
This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) (mFOLFOX6) or FOL/leucovorin, 5-fluorouracil and irinotecan (IRI) (FOLFIRI), and bevacizumab in participants with advanced solid tumors in a broad range of solid tumors. Participants with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with dostarlimab (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), as well as pharmacodynamics (PDy) data. Part 2A of the study will investigate the anti-tumor activity of TSR-033 and dostarlimab in combination in participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC). Part 2B of the study will investigate the safety and anti-tumor activity of TSR-033 and dostarlimab in combination with chemotherapy (Cohort B1: mFOLFOX6 and Cohort B2: FOLFIRI) and bevacizumab in participants with advanced or metastatic MSS-CRC.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: TSR-033, DRUG: Dostarlimab, DRUG: mFOLFOX6, DRUG: FOLFIRI, DRUG: Bevacizumab
Location: United States, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria for participants in Part 1:
* The participant is \>=18 years of age.
* The participant has any histologically or cytologically confirmed advanced (unresectable) or metastatic solid tumor and has PD after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
* The participant must have an archival tumor tissue sample that is formalin-fixed and paraffin-embedded (FFPE) (blocks preferred over slides) and requested and confirmed available from offsite locations prior to dosing. The quality and quantity of the sample must be confirmed sufficient as per the Study Laboratory Manual. Participants who do not have archival tissue must agree to a new biopsy to obtain fresh tumor tissue prior to dosing.
* Part 1b (PK/PDy cohort): The participant must have lesions amenable for biopsy and agree to undergo biopsies for fresh tumor tissue prior to treatment, approximately 4 to 6 weeks after treatment, and, whenever possible, at the time of PD and /or end of treatment (EOT). Serial biopsies are optional for participants in Part 1a and 1c.
* Female participants must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as:
* Participants \>=45 years of age and has not had menses for \>1 year.
* Amenorrheic for \<2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
* Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
* Female participants of childbearing potential (that is \[ie\], those who do not meet above criteria) must agree to use 2 highly effective forms of contraception with their partners, starting with the screening visit through 150 days after the last dose of study therapy.
* The participant must have an ECOG PS of \<=1.
* The participant has adequate hematologic and organ function, defined as:
* Absolute neutrophil count (ANC) \>=1500 per microliter (/μL).
* Platelets \>=100,000/μL.
* Hemoglobin (Hb) \>=9 grams per deciliter (g/dL) or \>=5.6 millimoles per liter (mmol/L).
* Serum creatinine \<=1.5 times upper limit of normal (× ULN) or calculated creatinine clearance (CrCL) \>=50 milliliters per minute (mL/min) using Cockcroft-Gault equation for participants with creatinine levels \>1.5 × institutional ULN
* Total bilirubin \<=1.5 × ULN and direct bilirubin \<=1× ULN (in the event that the total bilirubin result exceeds the upper institutional limits of normal, direct bilirubin will be obtained to determine eligibility).
* AST and ALT \<=2.5 × ULN unless liver metastases are present, in which case they must be \<=5 × ULN.
* INR of PT \<=1.5 × ULN, unless participant is receiving anticoagulant therapy, then PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants; aPTT) \<= 1.5 × ULN unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants.
Inclusion criteria for participants in Part 2:
* The participant is \>= 18 years of age.
* The participant has any histologically or cytologically confirmed CRC that is metastatic or not amenable to potentially curative resection (advanced), in the opinion of the Investigator.
* The participant has a primary and/or metastatic tumor(s) that is known to be MSS, as determined locally.
* The participant must have lesions amenable for biopsy and agree to undergo biopsies for fresh tumor tissue prior to treatment, approximately 4 to 6 weeks after, and, whenever possible, at EOT and/or the time of PD. If the participant has had a biopsy prior to entering the 28-day screening period, and within approximately 12 weeks of study treatment, that biopsy sample may be accepted as the Baseline fresh biopsy. Additionally, submission of sufficient high-quality archival tumor tissue is recommended, if available, to enable a longitudinal analysis of tumor biomarkers.
* The participant has measurable disease by RECIST v1.1.
* The participant has resolution to Grade \<=1, per CTCAE v5.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy, with the exception of peripheral neuropathy, which must have resolved to Grade \<=2, and except where otherwise noted in the eligibility criteria.
* Female participants must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication if of childbearing potential or be of non-childbearing potential. Non-childbearing potential is defined as:
* Participants \>=45 years of age and has not had menses for \>1 year.
* Amenorrheic for \<2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
* Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
* Female participants of childbearing potential (ie, those who do not meet above criteria) must agree to use 2 highly effective forms of contraception with their partners, starting with the screening visit through 150 days after the last dose of study therapy.
* The participant has an ECOG PS of \<=1.
* The participant has adequate hematologic and organ function, defined as:
* ANC \>=1500/μL.
* Platelets \>=100,000/μL.
* Hb \>=9 g/dL or \>=5.6 mmol/L.
* Serum creatinine \<=1.5 × ULN or calculated CrCL \>=50 mL/min using Cockcroft-Gault equation for participants with creatinine levels \>1.5 × institutional ULN
* Total bilirubin \<=1.5 × ULN and direct bilirubin \<=1× ULN (in the event that the total bilirubin result exceeds the upper institutional limits of normal, direct bilirubin will be obtained to determine eligibility).
* AST and ALT \<=2.5 × ULN unless liver metastases are present, in which case they must be \<=5 × ULN.
* INR of PT \<=1.5 × ULN, unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants; aPTT) \<= 1.5 × ULN unless participant is receiving anticoagulant therapy, then PT or PTT is within therapeutic range of intended use of anticoagulants.
* Urinary protein is \<=1+ on dipstick for routine urinalysis; if urine protein \>=2+, a 24-hour urine sample must be collected and must demonstrate \<1000 mg of protein in 24 hours to allow participation in the study.
* Baseline albumin \>=3.0 g/dL.
Inclusion Criteria for participants in Part 2A:
* The participant must have had at least 2, but no more than 3, prior lines of therapy in the advanced or metastatic setting. Adjuvant chemotherapy with radiographic progression \>12 months after the last dose will not be considered a line of therapy.
* The participant has progressed on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
* Fluoropyrimidine.
* Oxaliplatin: Participants treated with oxaliplatin in adjuvant setting should have progressed after 12 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease.
* Irinotecan.
* Participants whose disease is known to be RAS-wild-type must have been treated with cetuximab, panitumumab, or other epidermal growth factor receptor (EGFR) inhibitor for metastatic disease.
* Bevacizumab and/or another anti-angiogenic agent.
* Previous treatment with regorafenib and/or TAS-102 are allowed in the absence of contraindications and if these agents are available to the participant according to local standards.
* The time between a participants's last chemotherapy and enrollment must be \<=8 weeks.
Inclusion Criteria for participants in Part 2B:
* The participant has received \<=2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted).
Inclusion Criteria for participants in Part 2 Cohort B1:
* The participant has received first-line combination therapy consisting of bevacizumab or anti-EGFR antibodies with FOLFIRI and has experienced radiographic progression during or after first-line therapy. Radiographic progression \>12 months after the last dose of adjuvant therapy will not be considered a line of therapy.
* mFOLFOX6 therapy with bevacizumab is appropriate for the participant and is recommended by the investigator.
Inclusion Criteria for participants in Part 2 Cohort B2:
* The participant has received first-line combination therapy consisting of bevacizumab or anti-EGFR antibodies with FOLFOX (or variant) and has experienced radiographic progression during or after first-line therapy. Radiographic progression \>12 months after the last dose of adjuvant therapy will not be considered a line of therapy.
* FOLFIIRI therapy with bevacizumab is appropriate for the participant and is recommended by the investigator.
Exclusion Criteria for all participants:
* The participant has previously been treated with an anti-LAG-3 antibody.
* The participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
* The participant has a known concurrent, serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy, including human immunodeficiency virus (HIV), known active hepatitis B or hepatitis C, active infection, or active autoimmune disease.
* The participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
* The participant has a history of interstitial lung disease.
* The participant has not recovered (ie, to Grade \<=1 or to Baseline) from radiation- and chemotherapy-induced AEs, has received transfusion of blood products (including platelets or red blood cells), or has received administration of colony stimulating factors (including granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 3 weeks prior to the first dose of study drug.
* The participant is currently participating in an investigational study (therapy or device) or has participated in an investigational study within 4 weeks prior to the first dose of study drug.
* The participant has received prior anticancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days or less than 5 times the half-life of the most recent therapy prior to the first dose of the drug, whichever is shorter.
* The participant has received wide-field (full-dose pelvic) radiotherapy within 28 days prior to the first dose of study drug.
* The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
* The participant has experienced any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 12 months prior to first dose of study drug.
* The participant has received a prior autologous or allogeneic organ or transplantation.
* The participant has undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to the first dose of study drug.
* The participant has had a serious non-healing wound, ulcer, or bone fracture within 28 days prior to first dose of study drug.
* The participant has an elective or planned major surgery to be performed during the course of the trial.
* The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) in the 12 months prior to the first dose of study drug.
* The participant has an acute or subacute bowel obstruction, abdominal fistula, or history of chronic diarrhea which is considered clinically significant, in the opinion of the investigator.
* The participant has experienced a Grade \>=3 bleeding event within 3 months prior to the first dose of study drug.
* The participant has either peptic ulcer disease associated with a bleeding event or known active diverticulitis.
* The participant has not recovered (Grade \>=1) from AEs and/or complications from any major surgery prior to the first dose of study drug.
* The participant has received a vaccine within 7 days of the first dose of study drug.
* The participant has known hypersensitivity to TSR-033, dostarlimab (Part 1c and Part 2), or associated excipients.
Exclusion Criteria for participants in Part 1:
* The participant's prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-LAG-3 agent that resulted in permanent discontinuation due to an AE.
Exclusion Criteria for participants in Part 2:
* The participant has been previously treated with an anti-PD-1 or anti-PD-L1 antibody.
Exclusion Criteria for participants in Part 2B:
* The participant has known dihydropyrimidine dehydrogenase deficiency.
* The participant experienced an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 4 proteinuria, a Grade 3-4 bleeding event, or bowel perforation during first-line therapy with a bevacizumab-containing regimen.
* The participant has known hypersensitivity to bevacizumab, mFOLFOLX6 (Cohort B1) or FOLFIRI (Cohort B2), or associated excipients.
* The participant experienced PD within 12 months of last dose of adjuvant therapy. | 31,139 |
Study Objectives
Lymphomagenesis is partially known, and some risk factor are identified like those inducing immune deficiencies: chronic exposure to HIV, immune suppressor therapies or commun variable immunodeficiency. Parts of the mechanisms leading to NHL development after pesticide exposure are the disruption of immune surveillance against cancer cell. Pro-oncogenic action of metabolites is the most important mechanisms of action for pesticides. Thus, pesticides are metabolized in pro-oxidant compounds disturbing the redox homeostasis in the haematopoietic and immune cells precursors, promoting proliferation and survival, and inducing DNA breaks. Some of them induce direct DNA breaks and non-conform reparation, leading to activation of oncogenes; and other induces transcription factors for oncogenic signalling pathways. DNA reparation and adaptation to a higher ROS level are associated with resistance against cytotoxic chemotherapy treatment with induction of detoxification mechanism by tumour cells.
That DNA repair pathways, which are targeted by chemotherapy could also explain a part of chemo-resistance. It was therefore suggested that DLBCL dependence to specific DNA repair pathways could be targeted to hamper repair of intrinsic DNA damage occurring during B-lymphoma cells proliferation or to increase DNA damage induced by chemotherapy.
Conditions: Lymphoma Diffuse Large B-cell
Intervention / Treatment:
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
Adults treated for diffuse large B-cell lymphoma:
* Diagnosed between 2010 and 2015
* Included in ProLyPhy search
* Having received R-CHOP immuno-chemotherapy
* Supported in health facilities in Languedoc-Rousillon
Exclusion criterion:
NA | 36,280 |
Study Objectives
This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.
Conditions: Glioblastoma
Intervention / Treatment:
DRUG: Temozolomide, DRUG: Disulfiram, DIETARY_SUPPLEMENT: Copper gluconate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Diagnosis of histologically confirmed GBM (WHO grade IV).
* At least 18 years of age.
* ECOG performance status of at least 2.
* Has received or is in the process of completing a course of definitive radiotherapy of at least 45 Gy with concurrent temozolomide (patient may be registered before completing radiotherapy as long as it is anticipated that s/he will complete at least 45 Gy).
* Eligible for and planning to receive maintenance temozolomide after completion of definitive radiotherapy plus temozolomide.
* Willing to remain abstinent from consuming alcohol while on disulfiram.
* Meets the following laboratory criteria:
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin \> 9.0 g/dL (transfusion and/or ESA allowed)
* Total bilirubin ≤ 2x institutional upper limit of normal (ULN)
* AST and ALT \< 3 x ULN
* Calculated creatinine clearance must be \> 60 mL/min (by Cockcroft-Gault)
* Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Able to take oral medication.
* Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted).
Exclusion Criteria:
* Receipt of any other investigational agents within 14 days prior to study enrollment.
* Enrolled on another clinical trial testing a novel therapy or drug.
* History of allergic reaction to disulfiram.
* Treatment with clinically significant cytochromes P450 enzyme inducers, such as phenytoin, phenobarbital, chlordiazepoxide, diazepam, isoniazid, metronidazole, warfarin, amitriptyline within 14 days prior to the first dose of disulfiram. Of note, lorazepam and oxazepam are not affected by the P450 system and are not contraindicated with disulfiram.
* Active or severe hepatic, cardiovascular, or cerebrovascular disease, including myocardial infarction within 6 months prior to enrollment, have New York Heart Association (NYHA) Class III or IV heart failure (Appendix B), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* History of idiopathic seizure disorder, psychosis or schizophrenia.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of initiation of treatment. | 7,278 |
Study Objectives
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.
In this study, our hypothesis are as following:
1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Conditions: Benign Breast Neoplasm
Intervention / Treatment:
Location: Korea, Republic of
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* nonpalpable benign breast lesion ≤ 2cm in patients with breast cancer.
* patients who need breast biopsy as treatment for breast cancer.
* Eastern Cooperative Oncology Group Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years
Exclusion Criteria:
* nonpalpable benign breast lesion ≥ 2cm in patients with breast cancer.
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness | 25,231 |
Study Objectives
An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Conditions: Relapsed/Refractory Multiple Myeloma
Intervention / Treatment:
DRUG: IBI346
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
3. Measurable disease as defined by the protocol
4. ECOG score is 0 or 1.
5. Expected survival time ≥12 weeks.
Exclusion Criteria:
1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
3. No unmobilized mononuclear cells can be collected for CAR T cell production.
4. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day).
5. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). | 43,153 |
Study Objectives
Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation?
Conditions: Multiple Myeloma, Plasma Cell Disorder
Intervention / Treatment:
OTHER: Tai Chi, OTHER: Education
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Diagnosis of Multiple myeloma \> 18 years of age or greater
* English speaking
* General proficiency to read and write in English
* Able to attend training session per study protocol
* ECOG performance status 0-1
Exclusion Criteria:
* Currently performs Tai Chi, Qi Gong, or Yoga at least once weekly or more
* Syncopal event in prior 60 days
* Current Grade 3 or \> neuropathy
* Concurrent major depressive disorder or anxiety disorder (DSMIV)
* Chronic Dizziness and/or vestibular disorders | 43 |
Study Objectives
The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation.
Conditions: Prostate Cancer
Intervention / Treatment:
PROCEDURE: External beam radiation, PROCEDURE: Pd-103
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients with previously untreated prostatic cancer.
* Must have PSA 10-20 ng/ml, Gleason 7 to 9
Exclusion Criteria:
* Patients with proven regional lymph node involvement will be excluded. | 17,002 |
Study Objectives
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study.
Conditions: Metastatic Pancreatic Cancer
Intervention / Treatment:
DRUG: Gemcitabine and Erlotinib, DIETARY_SUPPLEMENT: Intravenous Vitamin C
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Metastatic pancreatic cancer
* Glucose 6 phosphate dehydrogenase status normal
* ECOG performance status 0-2
* Normal creatinine and transaminase
* Women of child-bearing potential confirm negative pregnancy test
Exclusion Criteria:
* Concurrent chemotherapy or radiotherapy
* Significant co-morbid disorders
* Significant psychiatric symptoms
* Prior treatment with gemcitabine
* Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids)
* Regular use of nonsteroidal anti-inflammatory agents
* Smoking more than 1 pack per day
* Excessive alcohol or drug use
* Enrollment in other experimental therapy
* Active infection
* Patients experiencing ongoing response to recent treatments | 11,028 |
Study Objectives
Research studies show that the type of fat in the diet may affect breast cancer risk. Fish oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow down the growth and development of breast cancer cells in laboratory studies of mice and breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer development in humans has not been adequately studied. Eating fish or taking fish oil may increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer development.
Persons in this study with do one of the following: (1) take two capsules daily of omega 3 fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.
This study is supported by funding from the National Fisheries Institute, Food Innovation Center of The Ohio State University, and The Ohio State University Comprehensive Cancer Center.
Conditions: Breast Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Lovaza-Omega 3 fatty acid capsules, OTHER: Dietary fish (canned salmon, albacore)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Increased risk for breast cancer based on family history, personal history
* Normal mammogram, clinical breast examination in the past 12 months
* \>1 year from pregnancy, lactation or chemotherapy
Exclusion Criteria:
* Concurrent malignancy or metastatic malignancy of any kind
* History of a bleeding tendency, use of anticoagulant medications
* Inability to undergo fine needle aspiration of breast adipose tissue
* Chronic use of omega-3 fatty acid supplements or regular consumption of \> 2 meals/servings of fish per week within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
* Known sensitivity or allergy to fish
* Standing regimen of full dose aspirin (325 mg/day or more), Non-steroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products. | 19,530 |
Study Objectives
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
Conditions: Carcinoma in Situ of Bladder
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* age 18 years old or greater
* diagnosis of CIS (physician defined in the medical record)
* treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
* willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117
Exclusion Criteria:
* route of administration of valrubicin other than intravesical | 20,182 |
Study Objectives
The purpose is to determine how Drotrecogin Alfa (activated) will affect patients with blood cancers who develop severe sepsis within 60 days of starting chemotherapy in preparation for bone marrow transplant (BMT).
Conditions: Sepsis, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Infection
Intervention / Treatment:
DRUG: Drotrecogin Alfa (activated)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Participants must have Leukemia, Lymphoma or Myeloma.
* Participants must have had hematopoietic stem cell transplantation(HSCT) within the past 60 days.
* Participants must have infection with either vasopressor dependent septic shock or ventilator-dependent respiratory failure.
* Participants must be on a breathing machine or require medication to maintain their blood pressure.
Exclusion Criteria:
* Participants must not have increased bleeding risk due to medical conditions or medications. | 10,657 |
Study Objectives
A randomized comparison clinical trial will be conducted in laparoscopic radical prostatectomy patients in the Weinberg PACU at the Johns Hopkins Hospital. 50 patients will be recruited and randomly assigned by a table of random numbers to either the music listening group (n=35) or the relaxation breathing group (n=35).
Conditions: Prostate Cancer
Intervention / Treatment:
BEHAVIORAL: Preferred music listening, BEHAVIORAL: Relaxation breathing narrative over hypnotic music listening
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria
* All adult male patients schedule to have a laparoscopic radical prostatectomy surgery who are ages 45 to 80 years of age
* All ethnic backgrounds
* All religions
Exclusion Criteria:
* All patients who do not speak or understand the English language to the extent that it precludes their ability to provide informed consent for the study | 312 |
Study Objectives
The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.
The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.
Conditions: Cancer, Fatigue, Chemotherapy
Intervention / Treatment:
DRUG: Modafinil, DRUG: sugar pill
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: QUADRUPLE | Inclusion Criteria:
* Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
* Patient is 18 years of age or older
* Patient is able to swallow medication
* Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater
Exclusion Criteria:
* Patient has ever taken modafinil (PROVIGIL)
* Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate \[Ritalin\], pemoline \[Cylert\]), or a monoamine oxidase inhibitor (MAOIs)
* Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
* Patient presently taking on a regular basis:
* an anticoagulant (Coumadin \[warfarin\], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
* alpha-interferon or interleukin-2,
* a corticosteroid (dexamethasone, prednisone, prednisolone)
* Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
* Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
* Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable | 19,855 |
Study Objectives
Evaluate the performance of the mHRME in a study of 3,000 women in San Salvador to assess whether mHRME imaging improves specificity of screening by VIA or HPV DNA without reducing sensitivity for cervical precancer and cancer.
Conditions: Cervical Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: HRME
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Women who are between the ages of 30 and 49 years of age
2. All women must have a negative urine or serum pregnancy test prior to any study procedure (within 7 days)
3. Intact cervix (patients who have undergone previous LEEP, cone and/ or cryotherapy are not eligible)
4. No history of invasive cervical cancer
5. Able and willing to provide informed consent
Exclusion Criteria:
1. Women \< 30 years of age or over 49 years of age
2. Women who have undergone a hysterectomy with removal of the cervix
3. Women who have had a previous LEEP, Cold knife cone and/or cryotherapy
4. Women who are pregnant or breastfeeding
5. Women with a history of invasive cervical cancer
6. Unable or unwilling to provide informed consent | 14,492 |
Study Objectives
Because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. Helical chest computed tomography (CT) is the standard method of excluding pulmonary metastases. However, CT lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. Biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. We found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on CT imaging features was limited (57% to 67% rate of correct classification). Also, there was only slight to moderate agreement in nodule classification between these reviewers.
Furthermore, of 50 children who have undergone pulmonary nodule biopsy at St. Jude in the last five years, 44% (22/50) had only benign nodules.
Adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (FDG) positron emission tomography (PET) and the fusion modality PET-CT are superior to diagnostic CT in distinguishing benign from malignant pulmonary nodules because FDG PET gives information about the metabolic activity of the nodule. Nodules that are malignant have more metabolic activity, hence more FDG uptake/intensity, than those that are benign. There has been little work done in children to determine the value of PET or PET-CT in the evaluation of pulmonary nodules.
Conditions: Pulmonary Nodules
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Participant has a known or clinically suspected solid malignancy (excluding brain tumor)
* Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy
Exclusion Criteria:
* Participant has not been off therapy for at least 3 weeks before undergoing PET-CT | 7,876 |
Study Objectives
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
Conditions: Pancreas Cancer, Biliary Tract Cancer
Intervention / Treatment:
OTHER: Alcohol Injection, OTHER: Placebo Injection
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE | Inclusion Criteria:
This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
* Physiologic suitability for major abdominal surgery
* Aged 18 years and older
* Written informed consent
* Ability to understand and comply with study guidelines.
Exclusion Criteria:
* Pregnancy
* Previous, preoperative celiac nerve block
* Neoadjuvant chemotherapy or radiation therapy
* Incomplete tumor resection (R2 resection, grossly positive resection margin)
* Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
* Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
* Known metastatic disease | 27,717 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients with prostate cancer that has not responded to hormone therapy.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: pegylated liposomal doxorubicin hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS: Histologically confirmed hormone refractory prostate cancer Castrate serum testosterone levels less than 30 mg/dL occurring at least 4 weeks since prior flutamide or at least 6 weeks since prior bicalutamide Measurable or evaluable progressive disease Rising PSA involving two determinations (one at least 20 ng/mL if PSA is sole criterion) at least two weeks apart OR Increasing measurable or evaluable disease OR New metastasis
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatic insufficiency Renal: Creatinine no greater than 2.0 mg/dL No renal failure Cardiovascular: Cardiac ejection fraction at least 50% by radionuclide ventriculogram No myocardial infarction within the past year No active angina No congestive heart failure No arrhythmias requiring medication Other: No active peptic ulcers No uncontrolled infection or other serious medical condition that would prevent compliance with chemotherapy No uncontrolled diabetes No spinal cord compression or carcinomatous meningitis
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroid therapy Concurrent gonadotropin-releasing hormone analogue allowed Radiotherapy: At least 2 months since prior radiotherapy (not to a measurable lesion) Concurrent palliative radiotherapy allowed Surgery: Not specified | 14,572 |
Study Objectives
Currently, if a radiologist finds a suspicious lesion seen only on a diagnostic Contrast Enhanced Digital Mammography (CEDM) exam requiring biopsy the biopsy procedure would likely be performed with MRI guidance because there are currently limited solutions to biopsy with CEDM guidance. Affirm Contrast Biopsy will provide an additional solution to biopsy/localize lesions found by using a CEDM imaging modality.
Conditions: Breast Cancer
Intervention / Treatment:
DEVICE: Affirm Contrast Biopsy procedure
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Females aged 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities
* Subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them
Exclusion Criteria:
* Subjects who require a Legally Authorized Representative (LAR) for Informed Consent
* Subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders
* Subjects who have had a previous allergic reaction to IV contrast agent | 25,127 |
Study Objectives
The goal of this clinical research study is find the highest tolerable dose of BMTP-11 when given to patients with prostate cancer that has spread. The safety of this drug will also be studied.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: BMTP-11
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Have histologically confirmed adenocarcinoma of the prostate, with clinically significant bone metastases exhibiting castrate-resistant progression. Progression is defined as any of the following: 1) New lesions or obviously worsening lesions on bone scan within the previous three months; 2) a PSA doubling time of \< 3 months; 3) New or progressive symptoms requiring a change in therapy that are referable to the cancer; 4) New extra-osseous lesions within the past 3 months
2. Have progression in the face of a serum testosterone of less than 50 ng/dL, and have either failed or refused chemotherapy
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
4. Have adequate bone marrow function defined as an absolute peripheral granulocyte count of \>/= 1,000/mm\^3 and platelet count of \>/= 140,000/mm\^3; hemoglobin \>/= 9.0 g/dL (without transfusion or growth factor support), unless the patient is \< 6 weeks from last cancer therapy in which case transfusion is allowed.
5. Have adequate hepatic function defined as a total bilirubin of \</= 1.5 mg/dl and AST \</= 2\* the upper limits of normal
6. Have adequate renal function defined as serum creatinine \</= 1.5\* the upper limits of normal or creatinine clearance \>/= 60 mL/min (measured or calculated). In the absence of hematuria, patients must have either a negative urinalysis for protein (i.e. no more than "trace" by dipstick) or a 24 hour urine collection showing less than 1,000 mg of protein/24 hour. In the presence of hematuria, patients may have up to 2,000 mg of protein/24 hour.
7. Have adequate cardiovascular function as defined by: i) a normal beta-natruetic peptide (BNP) with ii) no signs or symptoms suggestive of cardiac disease and iii) a normal Electrocardiography (ECG). Alternatively, patient not meeting all of these criteria is still eligible if he has both i) an echocardiogram showing an ejection fraction (EF) of 45% or greater (and no more than "mild" diastolic dysfunction) and ii) a Brain Natriuretic Peptide (BNP)of \< 200
8. Sign the current Institutional Review Board (IRB) approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution
9. Age \>/= 18 years old
Exclusion Criteria:
1. Small cell prostate cancer
2. Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy
3. Any of the following in previous 6 months: New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, cerebrovascular accident (including transient ischemic attack), pulmonary embolism or myocardial infarction (by ECG or serologic criteria)
4. Significant co-morbidity that could affect the safety or evaluability of participants, including: a) Chronically uncontrolled hypertension, defined conventionally as consistent systolic pressures above 140 or diastolic pressures above 90 despite therapy. Note that this is NOT a criterion related to particular BP results at the time of assessment for eligibility, nor does it apply to acute BP excursions that are related to iatrogenic causes, acute pain or other transient, reversible causes. (Please see further explanation in the Treatment Plan below)
5. (# 4 cont'd) b) uncontrolled diabetes mellitus (defined as Hgb A1c \> 8.5, or symptomatic hypoglycemic episodes \> 1 per week during the two months prior to eligibility evaluation, or more than 1 glucose excursion to \>300 mg/dL in prior two months--unless clearly iatrogenic and the cause has been eliminated),c) lung disease requiring supplemental oxygen, d) known chronic liver disease, or e) HIV infection
6. Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent. (Non-obstructive hydronephrosis in setting of prior urinary diversion is allowed.)
7. Overt psychosis, mental disability or being otherwise incompetent to grant informed consent or a history of non-compliance with medical care
8. Patients must not require ongoing therapy with non-steroidal anti-inflammatories (NSAIDs),other than low-dose (i.e. 81 mg or less) aspirin daily, i.v. vancomycin, aminoglycosides, or other potently nephrotoxic drugs, and must agree to abstain from NSAIDs for the duration of their participation in the trial
9. Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
10. Unwillingness to maintain adequate contraception measures for the entire course of the study
11. Any therapy for prostate cancer (other than ongoing androgen deprivation or associated hormonal therapies such as diethylstilbesterol, low-dose dexamethasone, megace, etc) in the two weeks prior to starting BMTP-11 | 10,016 |
Study Objectives
This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus
Conditions: Neuroendocrine Tumors
Intervention / Treatment:
DRUG: RAD001, DRUG: SOM230
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion and Exclusion Criteria:
Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:
* The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
* Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
* No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).
No intolerable toxicity during combination therapy with pasireotide LAR and everolimus | 30,521 |
Study Objectives
Background:
* Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
* These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.
Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.
Eligibility:
* Tissue samples will be obtained from the human cooperative network.
* Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.
Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.
Conditions: Stem Cells
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * INCLUSION CRITERIA:
The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.
EXCLUSION CRITERIA:
The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases. | 5,278 |
Study Objectives
The primary objective of this trial is to determine the safety and tolerability of BI 853520 monotherapy by defining the maximum tolerated dose (MTD) and recommending the dose for further trials in the development of this compound.
Secondary objectives are
* determination of the pharmacokinetic (PK) profile;
* exploratory pharmacodynamic analysis; and
* collection of preliminary data on anti-tumour efficacy.
Conditions: Neoplasms
Intervention / Treatment:
DRUG: BI 853520
Location: Canada, Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
Inclusion criteria
1. Patients with a confirmed diagnosis of advanced, measurable or evaluable, nonresectable and/or metastatic non-hematologic malignancy, which has shown to be progressive in the last 6 months as demonstrated by serial imaging
2. Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
3. Tumour tissue must be available for the determination of E-cadherin expression (archived tissue or fresh biopsy).
4. Recovery from reversible toxicities (alopecia excluded) of prior anti-cancer therapies (CTCAE grade \< 2)
5. Age = 18 years
6. Life expectancy = 3 months
7. Written informed consent in accordance with International Conference on Harmonisation/Good Clinical Practice (ICH/GCP) and local legislation, including consent for PK samples, for using an archived tumour sample for determination of Ecadherin status, for reviewing previous tumour scans (and for providing skin biopsies, in patients in dose finding phase enrolled before protocol amendment 03)
8. Eastern Cooperative Oncology Group (ECOG), R01-0787) performance score 0-1
Additional inclusion criteria in the expansion phase:
9. Patients must have measurable progressive disease within the last 6 months, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (version 1.1, R09-0262)
10. deleted
11. Patients must be willing to provide paired tumour biopsies for PD determination. Refer to section 5.6.3
12. Patients should fit into one of the categories described below:
I. Metastatic adenocarcinoma of the pancreas Patients should have preferably received at least one line of systemic treatment for metastatic disease and preferably not more than 2 prior regimens for metastatic disease.
II. Platinum-resistant ovarian carcinoma, defined as recurrence within 6 months after completion of prior platinum-based chemotherapy Patients should have received preferably no more than 5 previous lines of systemic treatment for metastatic disease.
III. Oesophageal carcinoma Patients with oesophageal carcinoma of adenocarcinoma- or squamous cell histology who have received preferably not more than 2 previous lines of systemic treatment for metastatic disease.
IV. Soft tissue sarcoma Patients should preferably have received no more than 2 previous lines of systemic treatment for metastatic disease.
Exclusion criteria:
* Serious concomitant non-oncological disease/illness
* Active/symptomatic brain metastases
* Second malignancy
* Pregnancy or breastfeeding
* Women or men who are sexually active and unwilling to use a medically acceptable method of contraception.
* Treatment with cytotoxic anti-cancer-therapies or investigational drugs within four weeks of the first treatment with the study medication | 11,286 |
Study Objectives
The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a four day chemotherapy regimen involving dexamethasone, cytoxan, etoposide, and cisplatinum, or DCEP with or without thalidomide. Another purpose is to find out what kind of side effects patients will experience.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Thalidomide, DRUG: Dexamethasone, DRUG: Cytoxan, DRUG: Etoposide, DRUG: Cisplatin, DRUG: G-CSF
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant. High risk is defined as any one of the following at the time of relapse:a) Plasma cell labeling index (PCLI) \> 1%, b) Bone marrow plasmacytosis \> or = 30%, c)Bartl grade \>or = 2 on bone marrow biopsy, or d)Cytogenetic abnormalities of chromosome 13, 11q, or any translocation at the time of relapse.
* Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
* Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
* Patients must have a SWOG performance status of 0-2. Patients with a poor performance status (3-4) based solely on bone pain, will be eligible.
* Patients must have adequate renal function, as defined by serum creatinine \< or = 3.0 mg/dl
* Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Pregnancy testing is not required for 1) women wh have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.
* Patients must have adequate bone marrow function, as defined by platelet count of 150,000/microliter, unless explained by extensive marrow plasmacytosis.
* Patients must be off chemotherapy (excluding steroids) and local radiotherapy for \> 3 weeks prior to entering the study
Exclusion Criteria:
* There must be no evidence of active infection requiring IV antibiotics
* No other concurrent therapy for myeloma is permitted while on protocol | 6,062 |
Study Objectives
Comparison of patients with operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without adjuvant SBRT.
Conditions: Head and Neck Cancer
Intervention / Treatment:
RADIATION: Stereotactic Body Radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pathologically proven recurrent or second-primary head-and-neck cancer receiving prior radiotherapy with or without chemotherapy.
* Prior radiotherapy to a dose of ≥50Gy
* No evidence of distant metastases
* Macroscopic complete salvage surgery with curative intent (surgery was not performed only for biopsy or palliation). Final pathology and imaging must indicate a R0 or R1 resection (no gross disease remaining).
* High-risk pathologic features must be present: compromised/positive surgical margins (≤ 2mm) or extra-nodal extension (patient with other high-risk features gross perinueral invasion, bone invasion, angiolyphatic invasion, or a constellation of these factors may be eligible based on case-by-case basis at discretion of principal investigator).
* Karnofsky Performance Status ≥60 (ECOG 0-2)
* Any number or type of prior chemotherapy is allowed (patient may receive concurrent or adjuvant systemic therapy such as cetuximab at the discretion of the treating oncologic team)
Exclusion Criteria:
* Evidence of distant metastases on any staging or imaging modality
* Women who are breast feeding, or have a positive pregnancy test (reproductive age should use effective birth control during study if randomized to SBRT treatment arm)
* Any patient with gross residual disease following salvage surgery
* Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigator. | 5,694 |
Study Objectives
This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells.
Conditions: Leukemia, Lymphoma, Non-Hodgkin
Intervention / Treatment:
DRUG: Atorvastatin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* \> 18 years old
* Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) subtypes:
* Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
* Extranodal marginal zone B-cell lymphoma
* Nodal marginal zone B-cell lymphoma
* Splenic marginal zone B-cell lymphoma
* Treatment criteria
* Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR
* Prior treatment: watchful waiting currently appropriate o OR
* Refractory disease
* Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)
* CT chest (date)
* CT abdomen (date)
* CT pelvis (date) OR
* Staging within 4 weeks prior to enrollment (CLL: CT not required)
* Total white blood cell count (WBC) (Value) (date)
* Absolute lymphoma cell count (ALC) (Value) (date)
* Measurable disease (Site) (Size) OR
* CLL (only): elevated absolute lymphoma cell count
* Disease amenable to biopsy (must check at least one):
* Circulating tumor cells
* Positive bone marrow
* Palpable involved site (such as lymph node) measuring \> 1.5 cm
* Eastern Cooperative Oncology Group performance status \<2 (Karnofsky \>60)
* Life expectancy of greater than 3 months
* Patients must have adequate organ and marrow function
* Absolute neutrophil count \> 1,000/uL
* Platelets \> 30,000/uL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio \< 2.5 x institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have negative BetaHCG at enrollment
Exclusion Criteria:
* Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* Not recovered from adverse events due to agents administered more than four weeks earlier
* Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month
* Not recovered from adverse events due to surgery performed 4 weeks earlier
* Receiving any other investigational agent. Known brain metastases
* Taken any statin within the past 6 months prior to enrollment in the trial
* Currently abuses alcohol
* Currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis
* Has 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: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin.
* HIV-positive patients receiving combination anti-retroviral therapy | 8,910 |
Study Objectives
This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
Conditions: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Intervention / Treatment:
DRUG: sunitinib malate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Diagnosis of relapsed multiple myeloma
* Measurable disease as defined by at least one of the following:
* Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
* Urine monoclonal protein \> 200 mg by 24-hour electrophoresis
* Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
* Monoclonal bone marrow plasmacytosis ≥ 30%
* Not a candidate for stem cell transplantation OR have undergone prior stem cell collection
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1,000/microliter (mcL)
* Platelets ≥ 75,000/mcL
* Hemoglobin ≥ 8 g/dL
* Total serum bilirubin normal
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal
* Creatinine \< 2.5 mg/dL
* Negative pregnancy test for women of childbearing potential
* No more than 4 prior therapies
* Stem cell transplantation and preceding induction therapy will be considered 1 therapy
* Prior anthracycline exposure or central thoracic radiotherapy that included the heart in the radiotherapy port allowed provided patient has a New York Heart Association (NYHA) class II or better cardiac function on baseline ECHO or multiple gated acquisition scan (MUGA)
* Concurrent bisphosphonates allowed
* At least 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inhibitors
* At least 12 days since prior and no concurrent CYP3A4 inducers
Exclusion Criteria:
* Pregnant or nursing women
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
* History of serious ventricular arrhythmia or corrected QT interval (QTc) prolongation
* Poorly controlled hypertension
* Any condition that impairs the ability to swallow and retain sunitinib malate tablets
* Patients with a preexisting thyroid abnormality who are unable to maintain thyroid function in the normal range with medication
* Other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
* Concurrent uncontrolled illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
* Patients who have not recovered from adverse events of prior therapy
* Chemotherapy or radiotherapy ≤ 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
* Any major surgery ≤ 4 weeks prior to study entry
* Nonmyelosuppressive agents ≤ 2 weeks prior to study entry
* Any other prior antiangiogenic agents
* Concurrent high-dose corticosteroids
* Concurrent chronic steroids (up to 20 mg/day prednisone equivalent) allowed for disorders other than amyloid; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* Concurrent therapeutic doses of coumarin-derivative anticoagulants
* Concurrent agents with proarrhythmic potential
* Concurrent combination antiretroviral therapy for HIV-positive patients
* Any other concurrent investigational agents or anticancer therapy | 31,782 |
Study Objectives
RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.
PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.
Conditions: Cancer
Intervention / Treatment:
BIOLOGICAL: therapeutic allogeneic lymphocytes
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
* No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Bilirubin \< 2.0 mg/dL
* AST \< 3 times upper limit of normal
* Creatinine \< 2.0 mg/dL
* Ejection fraction \> 40% on MUGA scan
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics | 39,268 |
Study Objectives
This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy.
The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy.
The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training.
The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.
Conditions: Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
Intervention / Treatment:
DEVICE: High-resolution ultrasound guided prostate biopsy, DEVICE: Standard ultrasound guided prostate biopsy
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* All men \> 40 years age and \<80 years of age with an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam).
* PSA\<50
* Clinical stage \< cT3
Exclusion Criteria:
* Men with a history of prostate cancer
* Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
* Men with known prostate volume (from prior imaging) of \> 60cc
* Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
* Men who are unable to provide their own informed consent | 10,877 |
Study Objectives
Gastrectomy is curative treatment for early gastric cancer (EGC). Recently, endoscopic submucosal dissection (ESD) has been accepted as standard treatment in selected patients with negligible risk of lymph node metastasis. However, there are limited data regarding the long-term outcomes of ESD in comparison with surgery. This protocol aims to compare overall survival rate, tumor recurrence, development of metachronous cancers after ESD and surgery.
Conditions: Early Gastric Cancer
Intervention / Treatment:
PROCEDURE: Surgery
Location: Korea, Republic of
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* differentiated type mucosal cancer without ulceration, regardless of tumor size
* differentiated type mucosal cancer with ulceration ≤ 3 cm in diameter
* superficial (SM1 \< 500 μm) submucosal cancer ≤ 3 cm in diameter
* undifferentiated type mucosal cancer without ulceration ≤ 2 cm in diameter
Exclusion Criteria:
* early gastric cancer in a remnant stomach
* gastrectomy due to metachronous lesions during follow-up period
* post-ESD additional surgery due to high risk of lymph node metastasis or the possibility of residual tumor | 24,724 |
Study Objectives
The trial is a feasibility study of a patient-reported outcome (PRO) monitoring for patients with multiple myeloma. Patients will report weekly PROs during treatment at our outpatient unit. The trial will describe the development of treatment-specific item lists to adequately capture relevant symptoms during therapy, evaluate the feasibility of the weekly symptom monitoring, and evaluate the healthcare professional usage of the system in clinical practice.
Conditions: Multiple Myeloma
Intervention / Treatment:
BEHAVIORAL: Weekly questionnaires
Location: Austria
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Informed consent form signed
* sufficient language proficiency in German
* no overt cognitive impairments
* reporting to use the internet at least once a month
* able to log into a website using an individualized username and password (tested when patients are introduced to the patient portal)
* patients are currently receiving active therapy for the treatment of their multiple myeloma | 2,117 |
Study Objectives
In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.
Conditions: Smoking
Intervention / Treatment:
BEHAVIORAL: TLC monthly, BEHAVIORAL: TLC quarterly, BEHAVIORAL: MTM, BEHAVIORAL: 4 week assessment, BEHAVIORAL: 8 week assessment
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE | Inclusion Criteria:
1. scheduled or has order for low dose CT screening for lung cancer, or is eligible for screening low-dose CT
2. current daily smoker (eligible smokers will have smoked during the past 30 days and on at least 5 out of the past 7 days; individuals who have made a recent quit attempt, for example, in anticipation of their low dose CT scan for lung cancer screening, will be eligible if during the last 30 days, when they were smoking regularly, they smoked on at least 5 out of 7 days of the week).
3. 55 to 79 years old,
4. Interested in quitting and willing to choose a quit smoking date within the next 12 weeks,
5. voluntary written consent
Exclusion Criteria:
1. Unstable psychiatric disease, unless stable in treatment for 3 months (smokers on mental health medication with any changes in medication in past 3 months require study MD approval to participate) - Smokers with stable psychiatric disease will be eligible; this baseline characteristic and related symptoms will be considered in analyses,
2. No hospitalization for mental health reasons in past 3 months; No thoughts of self-harm in past 2 weeks,
3. No recent cognitive impairment (difficulties planning or organizing daily activities, such as managing finances, having trouble remembering appointments, or forgetting the correct month of the year); participants reporting recent cognitive impairment will be given the 6-item Callahan Cognitive Screener and must score at least a 5 out of 6 to participate,
4. Participating in a formal quit program (such as tobacco cessation counseling with or without use of NRT, bupropion, or varenicline; Smokers using NRT will be eligible as long as they are not using it as part of a formal quit program),
5. No phone
6. Non-English speaking
7. Current diagnosis of lung cancer | 21,480 |
Study Objectives
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine
Conditions: Thyroid Neoplasms
Intervention / Treatment:
DRUG: Sorafenib (Nexavar, BAY43-9006), DRUG: Placebo
Location: Korea, Republic of, Saudi Arabia, Netherlands, Belgium, Austria, Germany, United States, Poland, China, Japan, Spain, France, United Kingdom, Denmark, Sweden, Russian Federation, Bulgaria, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
* Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
* Progression within 14 months (RECIST \[Response Evaluation Criteria in Solid Tumors\] should be used as a basis for the assessment of disease progression)
* RAI (radioactive iodine) refractory
Exclusion Criteria:
* Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
* Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives | 4,968 |
Study Objectives
The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 \[E1-, E2b-\]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.
Conditions: Colon Cancer, Lung Cancer, Breast Cancer
Intervention / Treatment:
BIOLOGICAL: AD5 CEA Vaccine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Criteria for Patient Eligibility
1. Histologically confirmed diagnosis of malignancy expressing CEA. Because this is a safety and immunogenicity study, patients are NOT required to have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
2. For all tumor types other than colorectal, the tumor must express CEA as defined by immunohistochemical staining (at least 50% of the tumor with at least moderate intensity of staining) or a tumor known to be universally CEA positive (i.e. colon and rectal cancer). If colorectal cancer then, pathologic or clinical confirmation of adenocarcinoma is required.
3. Patients must have received treatment with standard therapy known to have a possible overall survival benefit.
For the following common cancers, the following eligibility criteria apply:
* Colorectal cancer: Must have received and progressed through at least one line of palliative chemotherapy consisting of one of the following regimens:
* Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and oxaliplatin.
* Palliative chemotherapy for metastatic colorectal cancer with 5 fluorouracil (or capecitabine) and irinotecan.
* Palliative chemotherapy regimen for metastatic colorectal cancer that includes bevacizumab.
* Colorectal cancer patients currently receiving palliative single-agent bevacizumab or cetuximab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
* Breast cancer: Must have received and progressed through at least one line of chemotherapy for metastatic breast cancer consisting of one of the following regimens:
* Palliative anthracycline- or taxane-based chemotherapy
* Patients with tumors that over express HER2 (IHC 3+ or FISH+) must have received and progressed through at least one line of palliative therapy that combines trastuzumab with chemotherapy.
* Breast cancer patients currently receiving palliative endocrine therapy or single-agent trastuzumab will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
* Patients who have been treated or offered the options of treatment with Bevacizumab (option clearly stated in the consent form).
* Patients who have been treated or offered the options of treatment with Lapatinib (option clearly stated in the consent form).
* Lung cancer: Must have received and progressed through chemotherapy for metastatic disease consisting of one of the following regimens:
* Palliative platinum-based (cisplatin or carboplatin) chemotherapy if the patient has not received chemotherapy previously.
* Palliative taxane-based (docetaxel or paclitaxel) or vinorelbine chemotherapy if the patient has received chemotherapy previously.
* Lung cancer patients currently receiving palliative single-agent erlotinib or gefitinib will be eligible for this trial and may continue these therapies concomitant with study treatment (if they have been on these single agent therapies for at least 3 months).
* Pancreatic cancer: Must have received and progressed through chemotherapy including gemcitabine.
- Pancreatic cancer patients currently receiving palliative single-agent erlotinib will be eligible for this trial and may continue this therapy concomitant with study treatment (if they have been on this single agent therapy for at least 3 months).
* For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.
* Patients who have received and progressed through first-line palliative chemotherapy must be advised regarding second-line therapy before being enrolled on this investigational study.
4. Karnofsky performance score of 70% or higher
5. Estimated life expectancy \> 3 months
6. Age ≥ 21 years, but \< 75
7. Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5, PTT \<1.5X ULN
8. Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
9. Patients who have received prior CEA-targeted immunotherapy are eligible for this trial, if this treatment was discontinued at least 3 months prior to enrollment.
10. Patients who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
11. Ability to understand and provide signed informed consent that fulfills Institutional Review Board's guidelines.
12. Ability to return to the clinical site for adequate follow-up, as required by this protocol.
Criteria for Patient Exclusion
1. Patients with concurrent cytotoxic chemotherapy or radiation therapy should be excluded. There are no exclusions based on the number of prior chemotherapy, biologic, hormonal, or experimental regimens. Except for the permitted concomitant therapies (bevacizumab, cetuximab, trastuzumab, erlotinib, gefitinib, or hormonal therapy which patients must have been on for at least 3 months at the time of enrollment if they intend to continue them with the vaccine), there must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy (including radiotherapy) and study treatment. Patients must have recovered to grade 1 acute toxicities from prior treatment.
2. Patients with a history of or current brain metastases will not be permitted.
3. Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
4. Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
5. Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
6. Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
7. Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immunosuppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
8. Patients on steroid therapy (or other immunosuppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.
9. Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
10. Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
11. Patients will be allowed warfarin 1mg po qd other than for port prophylaxis.
12. Patients with metastatic disease which is determined to be resectable will be excluded. | 831 |
Study Objectives
The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.
Conditions: Carcinoma, Hepatocellular
Intervention / Treatment:
DRUG: JX-594 followed by sorafenib
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological confirmation or clinical/laboratory diagnosis of primary hepatocellular carcinoma (HCC)
* Cancer is not surgically resectable for cure
* Child Pugh A or B
* Performance Score: KPS score of ≥ 70
* Platelet count ≥ 50,000 plts/mm3
* Total bilirubin ≤ 2.5 x ULN
* AST, ALT \< 5.0 x ULN
* Acceptable coagulation status: INR ≤ 1.5 x ULN
* Acceptable kidney function: Serum creatinine \< 2.0 mg/dL
* Sorafenib naive or refractory to sorafenib therapy Tumor Status: At least one intrahepatic tumor, and at least ≥50% of the total intrahepatic viable tumor mass, measurable by CT and injectable under imaging-guidance (note: injected and/or viable tumors must be previously untreated or ≥20% increase in size since preceding local-regional treatment).
Exclusion Criteria:
* Known contraindications to sorafenib
* Pregnant or nursing an infant
* Significant immunodeficiency due to underlying illness (e.g. hematological malignancies, congenital immunodeficiencies and/or HIV infection/AIDS) and/or medication (e.g. high-dose systemic corticosteroids)
* History of exfoliative skin condition (e.g. severe eczema, ectopic dermatitis, or similar skin disorder) that at some stage has required systemic therapy
* Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
* Severe or unstable cardiac disease
* Current, known CNS malignancy
* Use of anti-platelet or anti-coagulation medication
* Use of the following anti-viral agents: ribavirin, adefovir, cidofovir (within 7 days prior to the first treatment), and PEG-IFN (within 14 days prior to the first treatment).
* Patients with household contacts who meet any of these criteria unless alternate living arrangements can be made during the patient's active dosing period and for 7 days following the last dose of study medication:
* Pregnant or nursing an infant
* Children \< 12 months old
* History of exfoliative skin condition that at some stage has required systemic therapy
* Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication | 39,011 |
Study Objectives
The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.
Conditions: Tumors
Intervention / Treatment:
DRUG: AZD2171
Location: Germany, Netherlands, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: QUADRUPLE | Inclusion Criteria:
* Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.
Exclusion Criteria:
* Prior treatment with a VEGF inhibitor
* Poorly controlled hypertension | 8,574 |
Study Objectives
This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.
Conditions: Cushing's Disease
Intervention / Treatment:
OTHER: Exams and questionnaires
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease
Exclusion Criteria:
* other cause of Cushing's syndrome
* known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
* patient does not understand french
* life expectancy of less than 6 months
* pregnant women
* dependent patient | 7,986 |
Study Objectives
A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.
Conditions: Advanced Cancer
Intervention / Treatment:
DRUG: ENMD-2076
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Have histologic proof of advanced cancer that has progressed after treatment and has no standard therapy that is curative or provides clinical benefit.
* Meet the modified RECIST Criteria or have disease that can be followed for clinical benefit.
* Are greater than or equal to 18 years of age.
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ ULN
* Creatinine ≤ 1.5 x ULN
* Absolute neutrophil count ≥ 1500 cells/mm3
* Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 9.0 g/dL
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
* Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments.
Exclusion Criteria:
* Women who are pregnant or nursing.
* Have received radiotherapy or chemotherapy less than two weeks prior to first dose of study medication and have not recovered from all acute toxicities from prior treatments.
* Have participated in any clinical trial involving conventional or investigational drugs within 28 days prior to initiation of ENMD-2076 dosing.
* Have active, acute, or chronic clinically significant infections.
* Have uncontrolled severe hypertension or congestive heart failure.
* Have active angina pectoris or recent myocardial infarction (within 6 months).
* Have chronic atrial fibrillation or QTc of greater than 470 msec.
* Have had major surgery within 21 days of starting therapy.
* Have planned surgical treatment of tumor(s)
* Have additional uncontrolled serious medical or psychiatric illness.
* Have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting.
* Have a 2+ protein by urinalysis or a history of nephrotic syndrome.
* Known central nervous system metastasis.
* Have history of deep vein thrombosis or pulmonary embolus, unless they are receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin. | 40,464 |
Study Objectives
RATIONALE: Activating white blood cells in the laboratory may help them kill more cancer cells when they are put back in the body. This may be an effective treatment for patients undergoing a stem cell transplant for multiple myeloma.
PURPOSE: This phase I/II trial is studying the side effects of activated white blood cells and to see how well they work in treating patients who are undergoing a stem cell transplant for newly diagnosed stage II or stage III multiple myeloma.
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Intervention / Treatment:
BIOLOGICAL: MILs, DRUG: Melphalan, BIOLOGICAL: PCV13
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma
* Newly diagnosed disease
* Durie-Salmon stage II or III disease
* Measurable disease, defined by any of the following:
* Measurable serum and/or urine M-protein levels documented and available prior to induction therapy
* Positive serum free light chain assay
* Must have completed a minimum of 3 courses of myeloma specific therapy
* Candidate for autologous stem cell transplantation
* Patients who have achieved a complete remission at the time of bone marrow harvest for marrow infiltrating lymphocytes (MILs) expansion are not eligible
* No evidence of spinal cord compression
* Diagnosis of the following cancers are not allowed:
* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
* Non-secretory myeloma (no measurable protein on serum free light chain assay)
* Plasma cell leukemia
* No amyloidosis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and up to day 180
* Corrected serum calcium \< 11 mg/dL and no evidence of symptomatic hypercalcemia
* Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
* ALT ≤ 2.0 times ULN
* Serum creatinine \< 2.0 mg/dL
* No history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer
* No history of autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring systemic treatment
* Hypothyroidism without evidence of Graves' disease or Hashimoto thyroiditis is allowed
* No infection requiring treatment with antibiotics, antifungal, or antiviral agents within the past 7 days
* No HIV infection
* No major organ system dysfunction including, but not limited to, the following:
* New York Heart Association class III or IV congestive heart failure
* Pulmonary disease requiring the use of inhaled steroids or bronchodilators
* Renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction that would impair ability to participate in the study
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior hematopoietic stem cell transplantation
* At least 3 weeks since prior corticosteroids (i.e., glucocorticoids)
* At least 3 weeks since prior myeloma-specific therapy
* At least 4 weeks since participation in any clinical trial that involved an investigational drug or device
* No concurrent therapy with any of the following:
* Corticosteroids (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone \[Decadron\])
* Inhaled steroids used for treatment of allergic rhinitis or pulmonary disease allowed
* Thalidomide
* Interferon
* Growth factors, interleukins, or other cytokines (except filgrastim \[G-CSF\] as outlined in the protocol, or erythropoietin)
* Cytotoxic chemotherapy agents (except cyclophosphamide for stem cell mobilization and high-dose melphalan)
* Immunosuppressive drugs
* Experimental therapies
* Radiotherapy | 43,806 |
Study Objectives
The primary purpose of this study is to examine the effect of a brief preoperative smoking intervention on postoperative complications in women undergoing breast cancer surgery.
Secondary purposes are to examine long-term smoking cessation rates and experienced stress and nicotine withdrawal symptoms during the smoking cessation period.
Conditions: Breast Cancer, Smoking
Intervention / Treatment:
BEHAVIORAL: Brief preoperative smoking intervention
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Woman
* Scheduled for elective breast cancer surgery
* Daily smoker
* Age 18 years and above
* Able to read and write Danish
* Informed consent.
Exclusion Criteria:
* Alcohol intake \>35 units per week
* Diagnosed psychiatric disease (including substance abuse and dementia)
* ASA IV and V
* Preoperative neo-adjuvant chemotherapy
* Ulcerating cancer
* Pregnancy and breast-feeding. | 1,456 |
Study Objectives
This pilot clinical trial studies dabrafenib and trametinib in treating patients with ameloblastoma and a specific mutation (change) in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Conditions: Ameloblastoma, BRAF Gene Mutation
Intervention / Treatment:
DRUG: Dabrafenib, DRUG: Trametinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological diagnosis of ameloblastoma; all stages are eligible; patients must have evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E or other known dabrafenib sensitive BRAF mutation in tumor by any Clinical Laboratory Improvement Amendments (CLIA) certified lab; may include, for example, Sanger sequencing, SNaPshot platform, immunohistochemistry, Foundation One tests, etc.)
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Absolute neutrophil count (ANC) \> 1.5 x10\^9/L
* Platelet (PLT) \> 99 x 10\^9/L
* Hemoglobin \> 8 g/dL
* Total bilirubin (Tbili) \< 1.6 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 2.6 x ULN
* Alkaline phosphatase (alk phos) \< 2.6 x ULN
* Serum creatinine \< 1.6 x ULN or creatinine clearance \> 50 ml/min
* Ability to understand and the willingness to sign a written informed consent document
* Patients of childbearing potential must agree to use effective contraception until at least 6 months after treatment with dabrafenib
* Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
* Left ventricular ejection fraction equal to or greater than normal
Exclusion Criteria:
* No prior treatment with agents targeting BRAF mutant tyrosine kinases or radiation of target lesions
* Invasive malignancy other than ameloblastoma within 3 years, excluding curatively treated basal cell carcinoma, and other highly curable cancers such as early stage cutaneous squamous cell carcinoma (T1 NO) cervical carcinoma in situ (CIS), early stage prostate cancer, thyroid cancer or breast cancer
* Uncontrolled hypertension, chronic heart failure (CHF), or other major medical illness
* Prior allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib
* Concomitant use of strong inhibitors (e.g., ketoconazole, nefazodone, clarithromycin, gemfibrozil) or strong inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St John's wort) of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8)
* Concomitant use of proton pump inhibitors, H2-receptor antagonists, antacids
* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Pregnant or nursing patients; women of childbearing potential must have a negative pregnancy test within 14 days of enrollment
* Electrocardiogram (EKG) with QTcB (Bazett's formula) \> 480 ms done within 14 days of enrollment
* Interstitial lung disease or pneumonitis
* A history of retinal vein occlusion (RVO)
* Congestive heart failure NYHA class III or worse (Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.)
* A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months | 31,437 |
Study Objectives
This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL.
Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
Conditions: Diffuse Large B-Cell Lymphoma (DLBCL), Follicular NHL Grade 3b
Intervention / Treatment:
DRUG: Rituximab
Location: Taiwan, Malaysia, Turkey, Estonia, South Africa, Sweden, Thailand, Slovenia, Slovakia, Austria, Israel, Australia, Romania, Latvia, Mexico, Hong Kong, Croatia, China, Macedonia, The Former Yugoslav Republic of, Czech Republic, Russian Federation, Peru, Serbia, Bosnia and Herzegovina, Brazil, Bulgaria
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
* CR, CRu
* ECOG/ 0.1 or 2
* Known IPI at time of diagnosis
* Age \> 18 years
* Negative pregnancy test
* Men must agree not to father a child during the therapy
Exclusion Criteria:
* Transformed lymphoma
* Secondary malignancy
* Evidence of CNS - involvement
* Significant cardiac disease
* Creatinine \> 2.0 mg/dl
* HIV, Hepatitis positive | 40,664 |
Study Objectives
This is an open-label, single arm study. Approximately 3-30 patients will be enrolled. Patients will receive Oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. Three patients will initially be treated at each dose level in sequential cohorts. Dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. Dose escalation will continue until establishment of the maximum tolerated dose (MTD) has been met.
Patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. If additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.
Conditions: Hematologic Malignancy, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Acute Myeloid Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Disease
Intervention / Treatment:
DRUG: Ciclopirox Olamine
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Age \> 18
2. Relapsed or refractory hematologic malignancies including AML, ALL, CLL, high risk myelodysplasia (International Prognostic Score \>2.5), CML blast crisis, multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma for which all potentially curative therapy options have been exhausted.
3. ECOG (Eastern Cooperative Oncology Group) performance status \< 2.
4. Biochemical values within the following range:
1. Serum creatinine \< 2x upper limit of normal.
2. Total bilirubin \< 2x upper limit of normal, AST (asparatate aminotransferase) and ALT (alanine aminotransferase) \< 5x upper limit of normal.
5. Ability to maintain adequate oral intake of medication.
6. Ability to understand and sign informed consent.
7. Toxicity from prior chemotherapy has resolved
Exclusion Criteria:
1. Uncontrolled systemic infection.
2. Uncontrolled intercurrent illness
3. Pregnant or breast feeding
4. Active CNS (central nervous system) disease
5. Neurologic symptoms related to intracurrent illnesses or unexplained causes
6. Psychiatric illness that would limit compliance with study
7. Receiving other systemic chemotherapy, other than hydroxyurea to control circulating blast counts, within 10 days of study entry. Hydroxyurea is permitted, however the dose must be stable and unchanged in the 7 days prior to initiation with ciclopirox olamine
8. Concurrent therapy with topical ciclopirox olamine.
9. Use of other investigational anti-cancer therapy within two weeks of study entry.
10. Use of oral or intravenous metal supplements including iron, copper, zinc and nickel.
11. Resting ejection fraction \< 50% | 37,767 |
Study Objectives
Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight \[b.w.\] \[=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization\], 6 weeks apart).
Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection
Conditions: Prostatic Neoplasms
Intervention / Treatment:
DRUG: Radium-223 chloride (Xofigo®, BAY88-8223) injection
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: BASIC_SCIENCE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Hormone refractory with evidence of rising prostate-specific antigen (PSA): Subject must be maintained on androgen ablation therapy with luteinizing hormone-releasing hormone agonist or have undergone bilateral orchiectomy
* Serum testosterone level required to be ≤50 ng/dL
* Subjects who have received prior antiandrogen drug therapy: Flutamide, nilutamide, or cyproterone acetate must have stopped at least 4 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation; bicalutamide must have stopped at least 6 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation
* PSA progression: Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur at a minimum of 1 week from the reference value (measure 1). This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the subject will still be eligible provided the next PSA measure (measure 4) is found to be greater than the second PSA value (measure 2)
* Skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
* Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
* Life expectancy: ≥6 months
* Laboratory requirements: Neutrophil count ≥1.5 x 109/L, platelet count ≥100 x109/L, haemoglobin ≥95 g/L, total bilirubin level within normal institutional limits, aspartate aminotransferase and alanine aminotransferase ≤2.5 times upper institutional limit of the normal range, S Creatinine ≤1.5 times upper institutional limit of the normal range
Exclusion Criteria:
* Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
* Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
* More than one regimen of previous cytotoxic chemotherapy
* Has received prior hemibody external radiotherapy
* Has a need for immediate external radiotherapy
* Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
* Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for \>/= 12 weeks before administration of study drug
* Patients who are \</= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
* Patients who have started or stopped systemic steroids, within a week prior to study drug administration, or are expected to be subject to changes in the systemic steroid medication
* Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
* Visceral (e.g. liver, lung) metastases from prostate cancer as assessed by abdominal/ pelvic CT or chest radiograph within six weeks before administration of study drug
* Lymph node metastases with short-axis diameter greater than 2 cm
* Bulky loco-regional disease
* Any other serious illness or medical condition, for example: any uncontrolled infection, any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV), Crohns disease or ulcerative colitis | 29,590 |
Study Objectives
The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.
Conditions: Gastrointestinal Neoplasms, Gastric Cancer
Intervention / Treatment:
DRUG: S-1, DRUG: S-1, DRUG: S-1, DRUG: S-1, DRUG: S-1, DRUG: S-1
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients undergoing R0, R1, R2 resection, or with unresectable or locoregional recurrent disease
* Any prior chemotherapy is allowed in this protocol.
* No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy.
* Karnofsky performance status(KPS)≥ 70,predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below:
* Leukocytes greater than or equal to 3,000 G/L
* Platelets: greater than or equal to 100,000/mm3
* Hemoglobin:greater than or equal to 10g/L
* Total bilirubin: within normal institutional limits
* AST/ALT: less than or equal to 1.5 times the upper limit
* Creatinine within normal upper limits
* Informed consent
* Without any serious complications,such as hypertension,coronary artery disease,psychiatric history.
Exclusion Criteria:
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis in liver,lung,,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females | 37,091 |
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
Location: United States, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | 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 | 28,397 |
Study Objectives
The purpose of the study is to test how well patients with advanced solid tumors respond to treatment with elimusertib (BAY1895344) in combination with pembrolizumab. In addition researchers want to find for patients the optimal dose of elimusertib in combination with pembrolizumab, how the drug is tolerated and the way the body absorbs, distributes and discharges the drug. The study medication, elimusertib, works by blocking a substance (ATR Kinase) which is produced by the body and is important for the growth of tumor cells. Pembrolizumab is an immunologic checkpoint blocker that promotes an immune response against the tumor.
Conditions: Advanced Solid Tumors
Intervention / Treatment:
DRUG: Elimusertib (BAY1895344), DRUG: Pembrolizumab (Keytruda®)
Location: Germany, United States, Spain, United Kingdom, Switzerland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* Participant must be ≥18 years of age inclusive, at the time of signing the informed consent.
* Presence of the putative biomarkers of DDR deficiency in tumor and/or other tissues (dose escalation only).
* Participants must have histologically confirmed solid tumors .
* Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1.
* Adequate bone marrow function as assessed by laboratory tests to be conducted within 7 days before the first dose of study intervention.
* Participants must have adequate kidney function, as assessed by the estimated glomerular filtration rate (eGFR) \> 40 mL/min per 1.73 m\*2 within 7 days before the first dose of study intervention.
* Participants must have adequate liver function as assessed by laboratory tests to be conducted within 7 days before the first dose of study intervention.
* Participants must have adequate coagulation, as assessed by laboratory tests as applicable, (to be conducted within 7 days before the first dose of study intervention) or be on stable anti-coagulation treatment.
* Adequate cardiac function per institutional normal measured by echocardiography (recommended) or multigated acquisition (MUGA) scan/cardiac MRI per institutional guidelines.
* Participants must have measurable disease (at least one measurable lesion) as per RECIST 1.1, or evaluable disease according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) classification as applicable. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Exclusion Criteria:
* Ongoing infections of Common terminology criteria for adverse events (CTCAE) grade ≥2 not responding to therapy or active clinically serious infections.
* Participants with
* Known human immunodeficiency virus (HIV)
* Active Hepatitis B infection (positive for Hepatitis B surface antigen (HBsAg)/ Hepatitis B virus (HBV) DNA).
* Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).
* Active autoimmune disease (active defined as having autoimmune disease related symptoms and detectable autoantibodies) that has required systemic treatment in the 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, etc.) is not considered a form of systemic treatment
* Diagnosis of immunodeficiency or participant is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.
* Pleural effusion or ascites that causes respiratory compromise (CTCAE Grade ≥ 2 dyspnea).
* History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \>II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted)
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)
* Moderate or severe hepatic impairment, i.e., Child-Pugh class B or C.
* History of organ allograft transplantation
* Evidence or history of bleeding disorder, i.e., any hemorrhage / bleeding event of CTCAE Grade \> 2 within 4 weeks before the first dose of study intervention | 20,865 |
Study Objectives
This phase II trial is studying how well trabectedin works in treating young patients with recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions: Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor
Intervention / Treatment:
DRUG: trabectedin, OTHER: pharmacological study
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must be greater than or equal to 12 months of age at the time of study entry and no more than 21 years of age when initially diagnosed with the malignancy to be treated on this protocol
* Histologically confirmed recurrent or refractory sarcoma tumors, including the following:
* Rhabdomyosarcoma
* Nonrhabdomyosarcomatous soft tissue sarcoma
* Ewing's sarcoma
* Measurable disease by imaging studies
* Lesions assessable only by radionuclide scans are not considered measurable
* If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size
* No significant amount of metastatic liver disease, defined as the following:
* Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function
* Performance status - Lansky 50-100% (10 years of age and under)
* Performance status - Karnofsky 50-100% (over 10 years of age)
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3 (transfusion independent)
* Hemoglobin at least 8.0 g/dL (transfusion allowed)
* No concurrent CYP3A4 inhibitors, including the following:
* Grapefruit juice
* Erythromycin
* Azithromycin
* Clarithromycin
* Rifampin and its analogs
* Fluconazole
* Ketoconazole
* Itraconazole
* Cimetidine
* Cannabinoids (marijuana or dronabinol)
* Leukotriene inhibitors used in asthma (e.g., zafirlukast, montelukast, or zileuton)
* Bilirubin no greater than upper limit of normal (ULN)
* Total alkaline phosphatase no greater than ULN
* Hepatic fraction alkaline phosphatase and 5 nucleotidase no greater than ULN
* SGOT and SGPT ≤ 2.5 times ULN
* Albumin ≥ 2.5 g/dL
* Gamma-glutamyl transferase \< 2.5 times ULN
* Maximum creatinine based on age as follows:
* 0.8 mg/dL (5 years of age and under)
* 1.0 mg/dL (6 to 10 years of age)
* 1.2 mg/dL (11 to 15 years of age)
* 1.5 mg/dL (over 15 years of age)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min
* No uncompensated congestive heart failure within the past 6 months
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 2 months after study participation
* No active uncontrolled infection
* Weight ≥ 15 kilograms
* More than 1 week since prior growth factors that support platelet or white blood cell number or function
* At least 7 days since prior biologic agents and recovered
* No prior allogeneic stem cell transplantation
* No other concurrent immunomodulating agents
* More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No more than 2 prior multi-agent chemotherapy regimens
* No other concurrent anticancer chemotherapy
* Concurrent steroids allowed
* At least 6 weeks since prior since prior extended radiotherapy and recovered
* No prior total body radiotherapy
* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated\*
* At least 7 days since prior enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin)
* No concurrent enzyme-inducing anticonvulsants
* No other concurrent investigational agents | 41,219 |
Study Objectives
The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.
Conditions: Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Lenalidomide
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Must understand and voluntarily sign an informed consent form
* Age ≥ 18 years at the time of signing the informed consent form.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Cytologically/histologically confirmed diagnosis of MDS with del 5q (isolated, blast count \<5%), IPSS low or intermediate-1.
* Transfusion dependency with at least 1 concentrates of erythrocytes within 8 weeks prior to first administration of study drug.
* Start of treatment with lenalidomide is the best therapeutic option for the patient according to the investigator's assessment There are - apart from individual cases with erythropoetin level lower than 500 U/l and allogeneic transplantation for younger patients - no authorized alternative treatment options. Chemotherapy with low dose cytosine arabinoside may result in hematologic improvement. However, concerning the risk-benefit-assessment this chemotherapy is more unfavorable than lenalidomide due to cytopenia and mutagenic effects.
* Female subjects of childbearing potential must:
* Understand that the study medication has a teratogenic risk
* Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception\*: (Implant,Levonorgestrel-releasing intrauterine system (IUS)\*\*,Medroxyprogesterone acetate depot, Tubal sterilisation, Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses, Ovulation inhibitory progesterone-only pills (i.e., desogestrel))
* Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
(\*) Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
(\*\*) Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
* Male subjects must
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
* Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
* All subjects must
* Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
* Agree not to share study medication with another person and to return all unused study drug to the investigator
Exclusion Criteria:
* Pregnant or lactating females
* IPSS intermediate-2 or high-risk
* Proliferative (WBC ≥ 12 x 109/L) CMML
* Any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) \< 1 x 109/L
* Platelet count \< 50 x 109/L
* Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \> 3.0 x upper limit of normal (ULN)
* Serum total bilirubin \> 1.5 mg/dL Degree of severity of anemia is no exclusion criteria due to intensive interindividual variations of the haemoglobin value at time of transfusion.
* Prior ≥ grade-2 NCI CTCAE allergic reaction to thalidomide
* Prior desquamating (blistering) rash while taking thalidomide
* Neuropathy ≥ grade 2
* Clinically significant anemia owing to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years
* Concomitant use of androgens (exception: treatment of hypogonadism)
* Concomitant use of specific treatments for MDS
* Known HIV-1 positivity
* Participation in another clinical study in the 4 weeks prior to enrollment or during this study
* Prior treatment with lenalidomide
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study. | 20,185 |
Study Objectives
Although evidence exists to support cancer rehabilitation, services are fragmented and rehabilitation professionals are consulted infrequently and often long after treatment ends, when chronicity of problems limits the impact of intervention. Therefore, the objective of this project is to develop, implement, and conduct a pilot evaluation of the Rehabilitation Consult (RC). The RC program goals are to increase knowledge about rehabilitation needs and resources to meet those needs; to establish individualized rehabilitation goals for HNC survivors and personalized action plans to meet those goals; and to provide support to HNC survivors for the implementation and evaluation of action plans. This project consisted of intervention development and pilot evaluation; this trial registration describes the pilot evaluation phase only.
Conditions: Head and Neck Neoplasms
Intervention / Treatment:
BEHAVIORAL: Rehabilitation Consult (RC)
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Adult survivors of HNC who have completed active treatment (surgery, radiation, chemotherapy or any combination thereof) within 1-18 months.
Exclusion Criteria:
* Lack of English fluency,
* Cognitive impairment, or concurrent major degenerative conditions likely to cause functional deterioration, and
* Known active cancer. | 7,001 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia.
PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.
Conditions: Chronic Lymphocytic Leukemia, Anemia
Intervention / Treatment:
BIOLOGICAL: Fludarabine plus Darbopoetin, DRUG: Fludarabine mono
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
* Previously untreated disease
* Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride
* Meets 1 of the following staging criteria:
* Binet stage A disease with B symptoms requiring treatment
* Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:
* Rapid disease progression
* Enlarged lymph nodes and organs
* Severe B symptoms
* Binet stage C disease
* Must have comorbidities (i.e., CIRS score \> 6)
* Must have restricted kidney function (i.e., creatinine clearance \< 70mL/min)
* No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)
PATIENT CHARACTERISTICS:
* Life expectancy \> 6 months
* Creatinine clearance \> 30 mL/min
* No active second malignancy
* No active bacterial, viral, or fungal infection
* No conditions that would preclude substitution of iron
* No severe myocardial, coronary, or respiratory insufficiency
* No severe liver insufficiency
* No known hypersensitivity to darbepoetin alfa
* No cerebral dysfunction that would preclude participation in the required study procedures
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent participation in another clinical trial | 5,219 |
Study Objectives
The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.
Conditions: Rectal Cancer, Locally Advanced Rectal Cancer, Hyperthermia, Hyperthermic Radiochemotherapy, Hyperthermic Chemoradiotherapy, Deep Regional Hyperthermia
Intervention / Treatment:
OTHER: Deep regional hyperthermia, RADIATION: Radiotherapy, DRUG: Chemotherapy (5-Fluorouracil)
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
* Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)
* International Union Against Cancer stages II or III
* ECOG PS 0/2
* Informed consent
Exclusion Criteria:
* Congestive heart failure (NYHA III/IV)
* History of myocardial infarction within the last 6 months.
* AV Block III
* Total hip replacement or major metal pelvic implants
* Cardiac pacemaker
* Contraindications for radiochemotherapy
* Contraindications for surgical tumor resection
* Previous pelvic radiotherapy or chemotherapy
* Active chronic inflammatory bowel disease
* Collagenosis
* Congenital diseases with increased radiosensitivity
* Pregnancy or breastfeeding
* Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal | 27,055 |
Study Objectives
The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
Conditions: Pancreas Neoplasms, Bile Duct Diseases
Intervention / Treatment:
PROCEDURE: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Location: Monaco, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients aged from 18 to older
* Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
* Signed consent
Non inclusion Criteria:
* Patient who have no indication for an ERCP
* Allergy to fluorescein
* Allergic rhinitis, asthma, eczema
* Pregnancy, breast feeding
* Patients with dialysis
* Patient with severe heart failure
* Patient with cirrhosis
* Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy | 24,696 |
Study Objectives
Vertical transmission of human papillomavirus (HPV) 6/11 leads to infection in the lower airway of neonates. The presence of HPV 6/11 may later cause juvenile onset recurrent respiratory papillomatosis (JORRP).
Conditions: Papillomavirus Infections
Intervention / Treatment:
Location: Taiwan
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* In order to get respiratory specimens at or below the larynx, intubated neonates younger than one-month-old admitted to our neonatal intensive care unit will be included in this study after getting informed consent from their families.
Exclusion Criteria:
* Unless the neonate's condition is too critical to have the following procedure performed, gestational age, co-morbidity and maternal status of HPV infection are not exclusion criteria for this study. | 14,054 |
Study Objectives
The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in patients with lung cancers.
Conditions: Lung Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:- Newly diagnosed patients with lung cancer who are undergoing surgical resection of their tumors Exclusion Criteria:- Patients without non-small cell lung cancer | 33,608 |
Study Objectives
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Intervention / Treatment:
DRUG: vorinostat, PROCEDURE: therapeutic conventional surgery, DRUG: bortezomib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Histologically confirmed glioblastoma multiforme
* Gliosarcoma or other grade 4 astrocytoma variant (e.g., giant cell glioblastoma) allowed
* Recurrent disease
* Must have evidence of tumor progression by MRI or CT scan after radiotherapy or after the most recent antitumor therapy
* Bidimensionally measurable or evaluable disease by MRI or CT scan
* Patients receiving corticosteroids must be on a fixed dose for at least 1 week prior to baseline scan
* ECOG performance status 0-2
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the last dose of vorinostat
* Willing to provide mandatory correlative laboratory tissue samples
* Able to take oral medications
* No uncontrolled infection
* No known hypersensitivity to any of the components of vorinostat or bortezomib
* No myocardial infarction or unstable angina within the past 6 months
* No congestive heart failure requiring use of ongoing maintenance therapy or history of life-threatening ventricular arrhythmias
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Psychiatric illness or social situation that would limit compliance with study requirements
* No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with proper assessment of safety and toxicity of the prescribed study regimens
* Not immunocompromised
* Patients known to be HIV positive are eligible provided there is no clinical evidence of an immunocompromised state
* No peripheral neuropathy ≥ grade 2
* No peripheral neuropathy with pain ≥ grade 1
* No congenital long QT syndrome
* No prolonged OTC interval (\> 450 msec)
* No other concurrent anticancer therapy (other than hormonal therapy)
* At least 8 weeks since prior radiotherapy
* More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless there is a separate lesion on MRI that is not part of the prior treatment field
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No more than 1 prior chemotherapy regimen\* for progressive/recurrent disease (stratum 1)
* Patients in stratum 2 may have received any number of prior chemotherapy regimens\* for progressive/recurrent disease
* More than 2 weeks since prior small molecule cell cycle inhibitors
* More than 7 days since prior valproic acid
* More than 7 days since prior category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
* Quinidine, procainamide, disopyramide
* Amiodarone, sotalol, ibutilide, dofetilide
* Erythromycin, clarithromycin
* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,lidoflazine
* More than 4 weeks since prior bevacizumab
* No prior treatment with vorinostat or bortezomib
* No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin,fosphenytoin, carbamazepine, phenobarbital, or primidone)
* No other concurrent potent CYP3A4 inducer (e.g., rifampin or St. John's wort)
* No other concurrent investigational therapy for the primary neoplasm | 30,094 |
Study Objectives
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
Conditions: Cervical Intraepithelial Neoplasia, Low-Grade Squamous Intraepithelial Lesions, Papillomavirus Infections
Intervention / Treatment:
DRUG: Aminolaevulinic acid, DRUG: Placebo
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Premenopausal women, 25-50 years of age
* Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
* Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
* Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
* Written informed consent signed
Exclusion Criteria:
* ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
* Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
* Undiagnosed vaginal bleeding
* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
* With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN)
* Pregnancy or nursing
* Previous physical therapy of LSIL/CIN1 after pathologic diagnosis
* Participation in any clinical studies within the last 30 days
* Subjects that the investigators judged to be not suitable to participate the study besides above | 25,951 |
Study Objectives
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
Conditions: Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC)
Intervention / Treatment:
DRUG: MDV3100
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy
* Progressive disease after prior androgen deprivation therapy (medical or surgical castration)
* For Expansion Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel
* For Expansion Cohort, the patient must have measurable lesions by RECIST
Exclusion Criteria:
* Metastases in the brain
* History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years
* Use of bicalutamide within 6 weeks prior to study
* Radiation therapy within 12 weeks prior to study
* Evidence of serious drug hypersensitivity | 19,815 |
Study Objectives
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
Conditions: Leiomyoma, Uterine Hemorrhage
Intervention / Treatment:
DRUG: Ulipristal acetate (UPA), DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* Pre-menopausal women, 18-50 years, inclusive.
* Cyclic abnormal uterine bleeding (heavy or prolonged).
* Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
* Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
* Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia
Exclusion Criteria:
* History of uterine surgery that would interfere with the study endpoints.
* Known coagulation disorder including bleeding disorder or clotting disorder.
* History of, or current uterine, cervix, ovarian, or breast cancer.
* Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal rang | 40,925 |
Study Objectives
This will be a randomized, open-label, sequential, single dose, 4-period crossover study. This study is being conducted to measure the relative bioavailability of the original gelatin capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose \[HPMC\] capsule and enteric coated tablet \[ECT\]) of afuresertib (AFU), in the fed and fasted state. The study will be composed of Screening, Treatment, and Follow-up Periods. Screening assessments to determine subject eligibility will be performed within 3 weeks prior to the first dose of study drug in the Treatment Period. Eligible subjects will be randomized to receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B: AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D: AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F: AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period). Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC, BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days after the last dose. A subject's total time involved in the study will be approximately 9 weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects will be randomized to receive each treatment sequence.
Conditions: Cancer
Intervention / Treatment:
DRUG: Afuresertib GC - Fasted State, DRUG: Afuresertib HPMC capsule - Fasted State, DRUG: Afuresertib ECT - Fasted State, DRUG: Afuresertib GC - Fed State, DRUG: Afuresertib HPMC capsule - Fed State, DRUG: Afuresertib ECT - Fed State
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
* Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent
* Body weight \>=50 kilograms (kg) and body mass index (BMI) \<=32 kg/m\^2 (square meter)
* A female subject is eligible to participate if she is of: (A) Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea (B) Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at Screening and prior to dosing, AND: agrees to use one of the acceptable contraception methods
* Male subjects with female partners of child-bearing potential must agree to use one of the acceptable contraception methods.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5 x Upper Limit of Normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc \<450 milliseconds (msec) or QTc \<480 msec in subjects with Bundle Branch Block
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of gastroesophageal reflux disease (GERD), dyspepsia, gastrointestinal (GI) bleeding, GI surgery that could affect motility
* History of atrial arrhythmias
* History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation
* Use of prescription or non-prescription medications, vitamins, and dietary or herbal supplements (including St John's Wort) within 7 days (or 14 days if the drug/supplement is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug until completion of the Follow-up Period, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study
* Unable to abstain from smoking tobacco or the use of nicotine-containing products while admitted to the clinic
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of Study Drug on Day 1 of Dosing Period 1, until completion of the Follow-up Period
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening
* History of heavy use of tobacco- or nicotine-containing products within 6 months prior to Screening.
* A positive drug/alcohol screen at Screening or upon check-in to the clinic on Day -1 of each Dosing Period
* A positive test for Human Immunodeficiency Virus (HIV) antibody
* Pregnant females as determined by positive serum hCG test at Screening or prior to dosing.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
* Lactating females
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day | 23,947 |
Study Objectives
The study proposes low-dose Y90 microspheres for therapy planning of HCC, as an alternative to Technetium (99mTc) albumin aggregated (MAA), to be a bioidentical therapeutic Y90 surrogate marker to better predict and thus achieve optimal therapeutic dosing.
Conditions: HCC, Cancer of Liver, Cancer
Intervention / Treatment:
DEVICE: SIR-Spheres microspheres
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Adults ≥ 18 years
2. Life expectancy of 6 months or more as determined by the investigator
3. HCC confirmed by Liver Reporting \& Data System (LIRADS) on MRI or CT
4. 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 for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
5. ≤3 lesions
6. Longest dimension of the largest lesion ≤7cm
7. Single lobe disease
8. No significant extrahepatic metastatic disease
9. Barcelona Clinic Liver Cancer Stage A, B or C
10. ECOG \< 2 (Appendix A)
11. Lesion(s) \<50% of liver volume
12. Bilirubin ≤ 2 mg/dL
13. Albumin ≥ 3 g/dL
14. PT/INR \< 2
15. AST/ALT ≤ 3 institutional upper limit of normal (ULN)
16. Platelet count \> 50,000/mcL
17. Lung shunt fraction of \<20% by planar MAA if dose modification results in inadequate dose delivered to the tumor(s)
18. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
19. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 12 week before the start of study therapy. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
u. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. v. The effects of Y90 microspheres on the developing human fetus are unknown. For this reason female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. Winship Protocol #: RAD4784 Version Date: Aug 22, 2019 20 \| P a g e w. FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of \[IND Agent\] administration. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
Exclusion Criteria:
* An individual who does not meet all the inclusion criteria in section. | 12,773 |
Study Objectives
Successful treatment of lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in the patient's body and seek to limit any unnecessary radiation to normal parts of the body. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) ("a PET scan") and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT) ("a perfusion scan"), before treatment and then again during treatment to see if this scanning helps predict how well the treatment works and how well the lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of the whole body and areas of active cancer. V/Q SPECT is an image mapping tool that helps assess how well the lungs are working. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where the cancer or the healthy lung is located.
The researchers are also doing blood and urine tests in this study to look for markers to see if this helps them determine the patient's risk of developing side effects from radiation to the lungs. The researchers hope by using these types of tests that they can have more information to help decrease the amount of toxicity patients have from this type of treatment. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
RADIATION: Response-driven Adaptive Radiation Therapy, DRUG: Carboplatin, DRUG: Paclitaxel, DEVICE: FDG-PET, DEVICE: V/Q SPECT, DRUG: Durvalumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must have FDG-avid and pathologically proven Stage IIA-IIIB non-small cell lung cancer.
* Patients must be considered unresectable or inoperable.
* Patients must be 18 years of age or older.
* Patients must have a Karnofsky performance (A measure general well-being and activities of daily life. Scores range between 0 and 100 where 100 represents normal and 0 represents death.) of score \> or = to 70.
* Patients must have adequate organ and marrow function.
* Patient must be willing to use effective contraception if female with reproductive capability.
* Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
* Patients with any component of small cell lung carcinoma
* Patients with evidence of a malignant pleural or pericardial effusion
* Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints
* Patients cannot tolerate concurrent chemotherapy
* Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
* Prisoners are excluded for this study. | 24,576 |
Study Objectives
Breast cancer is the most common cancer and the second cause of cancer mortality in women. There are approximately 200,000 new cases of breast cancer a year. Classically, breast cancers are divided into two groups, invasive and non-invasive. A mainstay of the treatment of both of these types is surgical resection not only for therapeutic purposes but also for diagnostic purposes. Breast conserving therapy includes surgical lumpectomy and post-operative radiation. However, despite best surgical practices, when patients undergo BCT anywhere from 20 - 40% of these patients have margins positive for cancer. This leads to increased rates of reoperation which are quoted to be as high as 30% and increased local recurrences.
There is an over expression of folate receptors located on the surface of many human carcinoma nodules.Specifically for breast cancer up to 33% of all breast cancers over express the folate receptor.
Folate-fluorescein isothiocyanate, or folate-FITC, also identified as EC-17, targets folate receptors over expressed in certain cancers such as breast cancer, and could help in better identifying the margins of the cancer thereby achieving negative margins.
Conditions: Resectable Breast Cancer
Intervention / Treatment:
DRUG: EC17
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Adult patients 18 years of age and older
2. Patients presenting with breast cancer presumed to be resectable by lumpectomy and/or mastectomy on pre-operative assessment
3. Good operative candidate
4. Subject capable of giving informed consent and participating in the process of consent.
Exclusion Criteria:
1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
2. Patients with a history of anaphylactic reactions to Folate-FITC or insects
3. At-risk patient populations
1. "People who would be easily lost to follow up (ex: People who are homeless or alcohol dependent)
2. Patients unable to participate in the consent process (children and neonates). | 5,732 |
Study Objectives
To determine the maximum tolerated dose (MTD) of OPB-51602
Conditions: Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
Intervention / Treatment:
DRUG: OPB-51602
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
2. Patients who are responsive or have relapsed following standard treatment
3. Patients capable of providing written informed consent
4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent
5. ECOG performance status score of 0-1
6. Life expectancy of at least 3 months
7. Adequate vital organ function
8. Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
Exclusion Criteria:
1. Patients with other primary malignant tumors
2. Symptomatic CNS involvement
3. Ongoing or active infection, or complication that is not controllable by medication or other means
4. Complication of uncontrolled cardiac disease
5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
6. Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment | 3,988 |
Study Objectives
This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.
Conditions: Hematologic Neoplasms, Lymphoproliferative Disorders, Leukemia, Leukemia, Lymphocytic, Chronic
Intervention / Treatment:
DRUG: Clofarabine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model:
Masking: NONE | Inclusion criteria:
* Diagnosis of chronic lymphocytic leukemia
* Diagnosis of other acute leukemia
* At least 2 weeks since prior chemotherapy, immunotherapy, and/or radiotherapy
* Recovered from toxic effects of prior therapy
* Bilirubin no greater than 2 mg/dL
* Creatinine no greater than 1.5 mg/dL
Exclusion criteria:
* Candidate for treatment of higher efficacy or priority
* Pregnant or nursing | 2,828 |
Study Objectives
The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.
Conditions: Oropharynx Cancer
Intervention / Treatment:
DRUG: Minocycline, DRUG: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE | Inclusion Criteria:
1. Patients with a pathologically proven diagnosis of oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
2. Patients \> = 18 years old.
3. Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
4. Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine \< upper limit of normal.
5. Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be \< 1.5 times the upper limit of normal. The screening results for the following must be \< 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be \< 2 times the upper limit of normal if available.
6. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
7. Patients must be willing to discontinue taking dong quai and/or St John's wort.
8. Patients must be willing and able to review, understand, and provide written consent.
Exclusion Criteria:
1. Patients receiving concurrent chemotherapy or concurrent biologic agent.
2. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician.
3. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
4. Bile duct obstruction or cholelithiasis.
5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction.
6. Pre-existing psychosis or bipolar disorder.
7. Hypersensitivity to any tetracyclines.
8. Patients on anticoagulants (ie warfarin/heparin).
9. Patients with INR \> 1.5.
10. Patients taking any tetracycline within the last 15 days.
11. Patients that are pregnant.
12. Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision). | 5,226 |
Study Objectives
To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.
So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.
Conditions: Upper Gastrointestinal Subepithelial Tumors
Intervention / Treatment:
PROCEDURE: unroofing biopsy, PROCEDURE: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Older than 19 years old and younger than 80 years old
* Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)
Exclusion Criteria:
* Patient who had bleeding tendency
* Any previous surgery on esophagus, stomach or duodenum
* Patients who can not be underwent sedated endoscopy
* Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
* Constrast related allergic disease | 196 |
Study Objectives
This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: spartalizumab (PDR001), DRUG: regorafenib
Location: Korea, Republic of, Netherlands, Singapore, Israel, Canada, Australia, Spain, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Key inclusion criteria:
1. Patients with metastatic colorectal adenocarcinoma.
2. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis
3. Patients must provide a newly obtained tumor tissue sample from a metastatic site
4. Patients with the presence of at least one lesion with measurable disease as per RECIST
5. Patients previously treated with two prior regimen as per standard of care and have experienced disease progression (including -VEGF and EGFR targeted therapies (if KRAS wild).
6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria:
1. Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
2. Patients with metastatic disease amenable to be resected with potentially curative surgery
3. Patients who have had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment
4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti- CTLA-4 antibodies, other checkpoint inhibitors | 20,663 |
Study Objectives
* To detect SRSF2 gene mutation by polymerase chain reaction (PCR) in the two types of t-MDS/AML which recognized in the WHO classification.
* Association between SRSF2 gene mutation and the presence of other cytogenetic abnormalities in the two types of t-MDS/AML which recognized in the WHO classification, e.g. (Loss of chromosome 7 or del(7q), del(5q), isochromosome 17q, recurrent balanced chromosomal translocations involving chromosomal segments 11q23 (KMT2A, previously called MLL) or 21q22.1 (RUNX1), and PML-RARA).
* Relationship between SRSF2 gene mutation and cumulative dose, dose intensity, time of exposure and prognostic criteria (disease free survival, overall survival and disease course).
Conditions: Therapy Related Myelodysplastic Syndrome and Therapy Related Acute Myeloid Leukemia
Intervention / Treatment:
DIAGNOSTIC_TEST: PCR and cytogenetics
Location: Egypt
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients with myelodysplastic syndromes (MDS), who fulfill the WHO criteria.
* Patients with acute myeloid leukemia (AML), who fulfill the WHO criteria.
* Patients must start therapy (cytotoxic agents and/or ionizing radiotherapy) before beginning of the study, with a documented history of a benign or malignant condition for which they had received therapy prior to the diagnosis of MDS or AML.
Exclusion Criteria:
* Patients not fulfill the WHO criteria for diagnosis of MDS and AML. | 31,888 |
Study Objectives
The goal of this clinical research study is to learn the results of multimodality (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer that occurs at the same time as pregnancy. Researchers want to evaluate the outcome of labor and delivery as well as evaluate the long-term health outcomes of children exposed to chemotherapy while in their mother's womb.
Conditions: Breast Cancer, Pregnancy
Intervention / Treatment:
DRUG: 5-Fluorouracil, DRUG: Cyclophosphamide, DRUG: Doxorubicin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
· All patients with primary breast cancer occurring during pregnancy will be eligible for enrollment.
Exclusion Criteria:
* Patients presenting with systemic metastases at time of diagnosis.
* Patients unwilling or unable to give informed consent.
* Patients who have received radiation therapy while pregnant
* Patients who have received chemotherapy during the first trimester of pregnancy or chemotherapy other than FAC. | 18,739 |
Study Objectives
Fatigue is a troublesome symptom for breast cancer patients, which might be mitigated with exercise. Cancer patients often prefer their oncologist recommend an exercise program, yet a recommendation alone may not be enough to change behavior. Our study will determine whether adding an exercise DVD to an oncologist's recommendation to exercise led to better outcomes than a recommendation alone.
Conditions: Cancer
Intervention / Treatment:
BEHAVIORAL: Oncologist Recommendation, BEHAVIORAL: Oncologist Recommendation + DVD
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Diagnosis of breast cancer
* Scheduled for a clinical appointment with a surgical, radiation or medical oncologist at Oregon Health \& Science University (OHSU)
* Capable of answering survey questions by phone
Exclusion Criteria:
* Not medically cleared to participate in low-intensity exercise | 2,725 |
Study Objectives
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Conditions: Myeloma, Lymphoma
Intervention / Treatment:
DRUG: Plerixafor
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Age 18-70 years
2. Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Up to 3 prior treatment regimens
5. Meet all eligibility requirements for autologous transplant
6. Adequate marrow function defined as white blood cells (WBC) \>3,000; ANC \>1,500/mm3; platelets \>75,000/mm3
7. Adequate renal function defined as creatinine clearance \> 30 mL/min by Cockcroft-Gault
8. Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin \< 2 times upper limit of normal
9. Able to provide informed consent
10. Women not pregnant and agree to use contraception
Exclusion Criteria:
1. High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
2. Brain metastases or carcinomatous meningitis
3. Previous treatment with high dose chemotherapy and autologous transplant
4. Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
5. Acute infection or unexplained fever \>38°C
6. Weight \> 175% of ideal body weight as defined by the Devine equation
7. Experimental therapy within 4 weeks
8. Cytokine administration in the previous 14 days | 25,853 |
Study Objectives
This phase II trial studies how well eribulin mesylate works in treating patients with osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth of tumor cells by disrupting the cell cycle.
Conditions: Recurrent Osteosarcoma
Intervention / Treatment:
DRUG: Eribulin Mesylate, OTHER: Pharmacological Study
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must have had histologic verification of osteosarcoma at original diagnosis
* Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria, and have relapsed or become refractory to conventional therapy
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients must have a life expectancy of \>= 8 weeks
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (6 weeks if prior nitrosourea)
* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent
* Bisphosphonates: at least 4 weeks since the completion of therapy with a bisphosphonate
* Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
* Radiation therapy (RT): \>= 2 weeks (wks) for local palliative RT (small port); \>= 6 months must have elapsed if prior craniospinal RT or if \>= 50% radiation of pelvis; \>= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL
* Platelet count \>= 75,000/uL (transfusion independent)
* Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or
* A serum creatinine based on age/gender as follows: (threshold creatinine values were derived from the Schwartz formula for estimating GFR)
* Age (12 to \< 13 years) - serum creatinine of 1.2 mg/dL
* Age (13 to \< 16 years) - serum creatinine of 1.5 mg/dL (male) and 1.4 mg/dL (female)
* Age (\>= 16 years) - serum creatinine of 1.7 mg/dL (male) and 1.4 mg/dL (female)
* Bilirubin (sum of conjugate + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 110 units per liter (U/L); for the purpose of this study, the ULN for SGPT is 45 U/L
* Serum albumin \> 2 g/dL
* Shortening fraction of \>= 27% by echocardiogram
* Ejection fraction of \>= 50% by radionuclide angiogram
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with congenital prolonged QT syndrome
* Patients with a baseline QT/corrected QT (QTc) interval \>= 501 msec
* Patients who are receiving drugs that prolong the QTc are not eligible
* Patients who have previously received eribulin, halichondrin B, or analogues of halichondrin B
* Patients who have grade \>= 2 peripheral neuropathy
* Patients who are receiving other cancer directed therapy at the time of enrollment
* Patients who have had major surgery within 3 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
* Pregnancy and breast feeding
* Female patients who are pregnant are ineligible
* Lactating females are not eligible unless they have agreed not to breastfeed their infants
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 18,025 |
Study Objectives
This study aims to investigate the treatment of previously untreated stage I-II Extranodal NK/T Cell Lymphoma with sintilimab, peg-aspargase and anlotinib, "sandwich" with radiotherapy.
The primary endpoint is the complete response rate (CRR) at the end of the treatment, and the second endpoints are CRR after two cycles of the combined regimen (CRR2), overall response rate (ORR) at the end of the treatment, survival time (OS and PFS) and toxicities.
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, Early Stage, Anlotinib, Peg-aspargase, Sintilimab, Phase Two, Open, Radiotherapy
Intervention / Treatment:
DRUG: Sintilimab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed NK/T cell lymphoma;
* Male or female: ≥18 and ≤70 years old;
* Eastern Cooperative Oncology Group (ECOG) status 0-3;
* Estimated survival time \> 3 months;
* No previous anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy or stem cell transplantation;
* At least one evaluable or measurable lesion complying with Lugano 2014 Standard (evaluable lesion: the examination show increased uptake of lymph nodes or extranodal areas (higher than that of the liver) by 18F-Fluorodeoxyglucose/ Positron Emission Tomography (18FDG/PET) and the PET and/or Computed Tomography (CT) features coincide with lymphoma characteristics; measurable lesion: sarcoidal lesions were longer than 15 mm or extranodal lesions were longer than 10 mm, and accompanied by increased 18FDG uptake). Increased liver diffuse 18FDG uptake without measurable lesions should be excluded.
* The main organs function well, namely, the following requirements were met one week before admission: Blood routine WBC ≥ 3.5×109/L, Hb ≥ 100g/L and PLT ≥ 90×109/L; Heart and liver function were normal (total bilirubin ≤1.5×ULN, ALT and AST ≤ 2.5×ULN), renal function was normal (serum creatinine ≤1.5×upper limitation of normal (ULN)), and without abnormal coagulation function.
* Fertile patients must undergo pregnancy tests (serum or urine) within 14 days prior to study enrollment and the results are negative, and they are willing to use effective contraception during the trial;
* The imaging evaluation was Ann Arbor stage I/II.
* Voluntary participation and signed the informed consent, good compliance, with follow-up.
Exclusion Criteria:
* Patients allergic of any of drug in this regimen;
* Pregnant or lactating women
* Participated in other clinical trials within the 4 weeks prior to enrollment;
* Previous treatments with small molecule tyrosine kinase inhibitors, including familinib,sorafenib, sunitinib, regofinib, anlotinib, furquintinib, etc.
* Imaging showed tumors have involved important blood vessels (e.g. enveloping internal carotid artery/vein), or by investigators determine highly likely during the follow-up study and cause fatal hemorrhage
* History of severe hemorrhage, or any bleeding events with a severe grade of 3 or more in CTCAE 4.0 within 4 weeks prior to enrollment
* Blood pressure unable to be controlled ideally with single antihypertensive drug therapy (Systolic blood pressure \> 140 mmHg, Diastolic Blood Pressure \> 90 mmHg); Clinically significant cardiovascular disease (e.g. activity) including history of CVA (within 6 months), myocardial infarction (within 6 months), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure; serious cardiac arrhythmia beyond drug control or potentially affecting experimental therapy.
* Active ulcer, intestinal perforation or intestinal obstruction;
* History of gastrointestinal perforation within 28 days prior to enrollment;
* Various factors affecting the oral administration and absorption of drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
* Abnormal coagulation or bleeding tendency (It must be satisfied that INR is under normal range without anticoagulant within 14 days prior to signing informed consent); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; on the premise that the international standardized ratio of prothrombin time (INR) is less than 1.5, small doses of warfarin (1 mg po, qd) or aspirin (no more than 100 mg qd) are allowed for preventive purposes.
* Arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to precancerous chemotherapy is excluded if it has been cured judged by the researchers) and pulmonary embolism.
* Renal insufficiency: routine urine tests indicate that urine protein is more than + +, or 24 hours urine protein is more than 1.0 g.
* Suffered major surgery within 28 days prior to enrollment;
* Received strong inhibitors of CYP3A4 within a week or strong inducers of CYP3A4 within 2 weeks prior to enrollment.
* Long-term non-healing wound or incomplete-healing fracture.
* Symptomatic brain metastases (confirmed or suspected);
* Severe or uncontrolled infections
* History of psychotropic drug abuse and unable to get rid of or with mental disorders;
* History of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history;
* Previous and present objective evidences including history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of pulmonary function.
* History of other malignancy within the last 5 years prior to enrollment, except for cured basal cell carcinoma of skin, cervix in situ carcinoma and superficial bladder cancer;Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment. | 29,282 |
Study Objectives
Patients who undergo in vitro fertilization with or without intracytoplasmic sperm injection (IVF / ICSI) often experience an impact on their quality of life and emotional maladjustment to treatment and outcome. Multiple contributors to this negative impact have been identified, including interference with professional activities, expenses related to fertility treatment and hormonal side effects. In-vitro maturation (IVM) of human oocytes obtained from minimally stimulated or unstimulated ovaries offers a more "patient friendly" treatment option than the conventional ovarian stimulation protocols for Assisted Reproductive Technology (ART) treatment. Historically, IVM has been offered to women with increased ovarian response (so-called "high responders"), typically women with polycystic ovaries (PCO/PCOS), who are at increased risk for ovarian hyperstimulation syndrome (OHSS) if conventional ART protocols are used. IVM treatment programs are characterised by a minimal administration of fertility hormones, are less disruptive to patients' daily life through a reduced need for hormonal and ultrasound monitoring, avoid a range of minor and major complications because of the reduced hormonal burden of this procedure, and aim to reduce the total cost for of infertility treatment.
To facilitate the application of IVM as a treatment that can potentially improve the overall patient experience, a study comparing the psychological impact of a conventional ovarian stimulation protocol versus an IVM protocol will be conducted; furthermore, a study investigating the differences in quality of life between the two subgroups will also be performed.
Socio-demographic data, medical characteristics and the following questionnaires will be collected: Specific questions for patients with fertility problems (FertiQol); Hospital Anxiety and Depression Scale (HAD) and an instrument to measure side effects designed by the research group. The study group (IVF patients and IVM patients) will be evaluated at three predefined time points: at intake, after oocyte collection and when the outcome after the first embryo transfer is known.
Descriptive analysis, intergroup comparisons and explanatory/predictive model of the dependent variables (quality of life, emotional adjustment) will be performed.
Conditions: Infertility, Female, Polycystic Ovary Syndrome, Psychological Stress, Quality of Life
Intervention / Treatment:
OTHER: Questionnaires
Location: Belgium
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Heterosexual or homosexual women enrolled to undergo ART treatment
* Patients with polycystic ovarian morphology (12 or more small follicles observed during a baseline pelvic ultrasound scan) or polycystic ovary syndrome (PCOS) (Rotterdam criteria, 2003)
Exclusion Criteria:
* Medical contra-indication for pregnancy
* High (\>grade 2) grade endometriosis
* Patients who have previously undergone ART treatment
* Patients who require ART with PGD
* In vitro fertilisation with sperm retrieved through testicular biopsy
* Singles without a partner
* Couples who because of the language barrier (poor knowledge of Dutch, French or English) cannot reliably fill out the questionnaire. | 35,094 |
Study Objectives
The main endpoint is physiological rehabilitation after VATS-L under early mobilization. The secondary endpoints are exploring the effect of early mobilization on postoperative physiology.
Investigators hypothesis that early mobilization is clearly advantaged to advance the physiological recovery.
Conditions: Lung Neoplasm, Physiology, Exercise, Lung Function, Arterial Oxygen Saturation
Intervention / Treatment:
BEHAVIORAL: Early mobilization
Location: Denmark
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. VATS lobectomy;
2. Speak and understand Danish or English;
3. Informed consent obtained.
Exclusion Criteria:
1. Co-VATS lobectomy (more than one lobe resection);
2. Supplementary oxygen therapy later 6 h after surgery;
3. No willing to wear electronic device;
4. No willing to exam arterial oxygen saturation. | 33,095 |
Study Objectives
The purpose of this study is to compare the effects of Paclitaxel/Carboplatin and Lonafarnib to those of Paclitaxel/Carboplatin in primary treatment of patients with epithelial ovarian cancer.
Conditions: Epithelial Ovarian Cancer
Intervention / Treatment:
DRUG: Lonafarnib
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE | Inclusion Criteria:
* Previously untreated patients with a histologically confirmed diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors FIGO stage IIB-IV, regardless of measurable or non-measurable disease
* Age \>= 18 years
* ECOG performance status \<= 2
* Life-expectancy of at least 6 months
* Adequate bone marrow, renal and hepatic function:
WBC \>= 3.0 x 10\^9/l; Neutrophils (ANC) \>= 1.5 x 10\^9/l; Platelets \>= 100 x 10\^9/l; Hemoglobin \> 6 mmol/l (\> 10.0 g/dl); Bilirubin \<= 1 x upper limit of normal range; Alkaline phosphatase \<= 2.5 x upper limit of normal range; estimated GFR \>= 50 ml/min according to Jelliffe or Cockroft-Gault formula
* Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication and constraints of the protocol
* Patients must be geographically accessible for treatment and follow-up
* Time between definitive surgery and randomization into the study \<= 6 weeks
Exclusion Criteria:
* Ovarian tumors of low malignant potential (borderline tumors)
* Non-epithelial ovarian or mixed epithelial/nonepithelial tumors (e.g. Mixed Mullerian tumors)
* Patients who have received previous chemotherapy or radiotherapy
* Prior treatment with FT inhibitors
* Patients with a prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
* Complete bowel obstruction or the presence of symptomatic brain metastases
* Concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
* Patients with a history of seizure disorder or central nervous system disorders; pre-existing motor or sensory neurologic pathology or symptoms \> NCI grade 1
* History of congestive heart failure (NYHA Classification \> 2, even if medically controlled.
* History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
* History of atrial or ventricular arrhythmias (\>= LOWN II)
* Patients with significant Fridericia QTc (QTcF) prolongation at Baseline (ie. QTcF \>= 470 msec)
* Patients with severe active infection
* Patients with a history of severe hypersensitivity reactions to products containing Cremophor EL (cyclosporin or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to Carboplatin and Paclitaxel
* Women with childbearing potential and who are sexually active and unwilling to use a medically acceptable method of contraception (oral contraceptive, diaphragm with spermicide, intrauterine device, condom with spermicide)
* Women who are pregnant or breast feeding
* Administration of other anticancer therapy or simultaneous chemotherapeutic and/or hormonal drugs, or radiotherapy during the study treatment period (except: hormonal replacement therapy and/or steroid antiemetics)
* Patients who are participating in any other clinical study
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent | 31,278 |
Study Objectives
In a prospective case-control study, 140 medical students (,novices') and 10 Senior gynecologists (,experts') will perform a Large Loop Excision of the Transformation Zone (LLETZ) on a Training model afte having undergone a Video Training session. Their LLETZ-Performance will be assessed using an Objective Structured Assessment of Technical Skills (OSATS) protocol designed for judging the surgical proficiency when performing a LLETZ. Using metrical and non-metrical data points, construct validity of the LLETZ training model to distinguish between experts and novices will be assessed. Secondary endpoints are differences in OSATS scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.
Conditions: Cervical Dysplasia
Intervention / Treatment:
PROCEDURE: LLETZ on a training model
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Medical Student
* no previous experience with the Training model
* no previous experience in gynecological surgery
Exclusion Criteria:
* language barrier
* unwillingness to participate | 32,395 |
Study Objectives
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
Conditions: Metastatic Breast Cancer, Locally Advanced Breast Cancer
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Bevacizumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Must be female and greater than or equal to 18 yrs of age
* Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
* Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
* Participants may have received prior hormone therapy for locally recurrent or metastatic disease
Exclusion Criteria:
* Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
* Prior chemotherapy or targeted therapy for metastatic breast cancer
* Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
* History of, or active brain mets
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
* Prior history of high blood pressure crisis
* Have a serious, nonhealing wound, ulcer, or bone fracture | 28,826 |
Study Objectives
FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients.
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Transplant-Related Hematologic Malignancy
Intervention / Treatment:
DRUG: Fludarabine, DRUG: ARA-C, DRUG: Treosulfan, PROCEDURE: Peripheral Blood Stem Cell Transplant
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pts with de novo or secondary AML or with Int 2 or High risk MDS according to IPSS.
* Pts unable or unfit to receive SCT from an HLA (human leukocyte antigen)-identical related (SIB) or unrelated (MUD), or HLA-haploidentical related (HAPLO) donor.
* Hematologic CR (Appendix D) after 1 or 2 cycles of induction standard chemotherapy.
* Successful collection of autologous PBSC: ≥ 5.0x10e6 /kg patient bodyweight (BW)
* Age ≥ 65 years.
* Performance status 0-2 ECOG (Eastern Cooperative Oncology Group), 60-100% Karnofsky (Appendix E).
* Written informed consent.
Exclusion Criteria:
* Diagnosis of AML M3.
* Second concomitant malignancies.
* Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function).
* Known and manifested malignant involvement of the central nervous system (CNS)
* Active infectious disease
* HIV- positivity or active hepatitis infection
* Impaired liver function (bilirubin \> 1.5 x upper normal limit; transaminases \> 3.0 x upper normal limit)
* Impaired renal function (creatinine-clearance \< 60 ml/min; serum creatinine \> 1.5 x upper normal limit).
* Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine
* Participation in another experimental drug trial within 4 weeks before day -6
* Non-cooperative behaviour or non-compliance
* Psychiatric diseases or conditions that might impair the ability to give informed consent | 2,264 |
Study Objectives
This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.
Conditions: Uterine Cervical Cancer
Intervention / Treatment:
OTHER: Adaptative treatment plan, RADIATION: External radiotherapy
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Cervix carcinoma proved by histology
* According International Federation of Gynecology and Obstetrics (FIGO) classification, stages IB2, IIA, IIB, IIIA and IIIB without lumbo-aortic lymph node damage (surgical or radiologic)
* Patient treated with radio-chemotherapy then curietherapy with curative aim, validated in multidisciplinary meeting
* Renal, hepatic and cardiovascular functions that allow administration of the associated systemic treatment
* Older than 18 years
* Good general status, World Health Organization less or equal to 1
* Signed informed consent
Exclusion Criteria:
* History of cancer that is not controlled and / or treated for less than 5 years (excepted for cutaneous baso-cellular cancer)
* History of pelvic irradiation
* Simultaneous participation to another research that could interfere with the study results
* Pregnant or breastfeeding patient
* Patient under tutor or guardian
* Patient not able to respect medical follow-up for geographical, social or psychological reasons
* Not affiliated to a system of French social security | 27,439 |
Study Objectives
The purpose of the research is to: develop an educational website to empower Black and African American cancer patients to make informed decisions about personalized cancer treatment and clinical trials.
Conditions: Clinical Trials, Immunotherapy
Intervention / Treatment:
BEHAVIORAL: PINPOINT Digital Educational Tool
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria for Patient Key Informant:
* Age 18 and older
* Self-identify as Black/African American
* Diagnosed with solid tumor
* Able to read and speak English fluently
* Able to provide electronic informed consent
* Able to complete 2 surveys and an in-depth interview
Inclusion Criteria for Relative Key Informant:
* Age 18 and older
* Spouse, blood relative, or caregiver of a cancer patient who identifies as Black/African American
* Able to read and speak English fluently
* Able to provide electronic informed consent
* Able to complete 2 surveys and an in-depth interview
Inclusion Criteria for Provider Key Informant:
* Age 18 and older
* Physician, nurse, social worker, patient navigator, or financial counselor
* Work in oncology setting
* Able to read and speak English fluently
* Able to provide electronic informed consent
* Able to complete 1 survey and an in-depth interview | 19,196 |
Study Objectives
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.
Conditions: Bladder Cancer
Intervention / Treatment:
DRUG: Apaziquone, DRUG: Placebo, PROCEDURE: TURBT
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria: (All questions must be answered YES)
* Has the patient given written informed consent?
* Is the patient at least 18 years old?
* Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2?
* If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
* If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days?
* Is the patient willing and able to abide by the protocol?
Exclusion Criteria: (All questions must be answered NO)
* Does the patient have more than 4 bladder tumors?
* Does any single bladder tumor exceed 3.5 cm in diameter?
* Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor \<0.5 cm?
* Has the patient ever received Apaziquone?
* Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade \[WHO/ISUP classification\])?
* Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma?
* Does the patient have, or has the patient ever had, carcinoma in situ (CIS)?
* Does the patient have an active urinary tract infection?
* Does the patient have a bleeding disorder or a screening platelet count \< 100 x 10\^9/L?
* Does the patient have any unstable medical condition that would make it unsafe for him/her to undergo TURBT under general or spinal anesthesia?
* Does the patient have a screening hemoglobin \< 10 mg/dL, a screening absolute neutrophil count \< 1.5 x 10\^9/L or a screening creatinine \> 2 mg/dL?
* Does the patient have a known immunodeficiency disorder?
* Has the patient received any investigational treatment within the past 30 days?
* Is the patient breast feeding?
* Does the patient have a history of interstitial cystitis?
* Does the patient have a history of allergy to red color food dye?
* Has the patient had transitional cell carcinoma of the bladder within the past 4 months? | 21,645 |
Study Objectives
A medical review chart study in Japan to describe the treatment patterns and outcomes of patients with kidney cancer that is unable to be removed by surgery or that has spread. The clinical data is to be abstracted using electronic data capture (eDC) from patient medical records in Japan.
Conditions: Renal Cell Carcinoma
Intervention / Treatment:
Location: Japan
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* Adults 20 years and older at the time of initial diagnosis of mRCC
* Alive or deceased as of the date of data collection
* Diagnosis of mRCC between 01-Jan-2012 and 31-Aug-2015
Exclusion Criteria:
* Previously and/or currently enrolled in RCC clinical trials
* Patients have primary cancer other than renal cell cancer | 39,725 |
Study Objectives
This study is to assess the efficacy and safety of lenalidomide in combination with adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: Lenalidomide, DRUG: Adriamycin, DRUG: Dexamethasone
Location: Greece
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Subjects able to read and understand the Informed Consent Form (ICF).
2. Subjects willing to participate in the study and comply with its procedures.
3. Subjects who have signed the ICF
4. Newly diagnosed patients with symptomatic MM according to the criteria of IMWG
5. Subjects eligible for autologous stem cell transplantation
6. Age 18-70 years, of either sex
7. karnofsky ≥ 60
8. Platelets ≥ 100x109/L
9. Neutrophils ≥ 1.5x109/L
10. Alanine transaminase (ALT) \& Aspartate transaminase (AST) ≤ 3-fold of upper normal limit
11. Bilirubin ≤ 2-fold of upper normal limit
12. Creatinine clearance ≥60 ml/min
13. Expected survival ≥ 6 months as per PI's clinical judgment
14. Subjects able to tolerate aspirin, low molecular weight heparin or coumarinic agents as prophylactic anticoagulation
15. Female subject of childbearing potential must have 2 negative serum pregnancy tests (hCG) at Screening (once within 10-14 days and once 24 h before the study drug administration) and if sexually active must be using two medically acceptable, highly effective, adequate forms of birth control (ie, failure rate \<1% per year when used consistently and correctly) prior to Screening and and for time period at least 28 days before the study drug administration and agree to continue using it while being in the study (Screening and Treatment Periods including dose interruptions). A female subject should continue using a highly effective method of birth control for 30 days following the end of treatment.
16. A male subject must agree to use an adequate form of contraception for the duration of the study, while taking the study drug, during dose interruptions at for at least 28 days after the last dose of study drug even if he has had a successful vasectomy and agree to have sexual relations only with women who use a highly effective birth control method.
17. Subjects must be free of any clinically significant disease (other than MM) that would interfere with study evaluations
Exclusion Criteria:
1. Pregnancy, breastfeeding οr intention of pregnancy during the trial
2. Suspected or known hypersensitivity to any of the study drugs
3. Ongoing severe infection requiring intravenous antibiotic treatment
4. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. Concurrent prostate cancer for which the patient is receiving therapy will not be considered an exclusion if the Prostatic specific antigen (PSA) has been stable for 3 years
5. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
6. Myocardial infraction within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
7. Uncontrolled medical problems such as diabetes, coronary artery disease, hypertension, unstable angina, arrhythmia, pulmonary, hepatic and renal diseases unless renal insufficiency is considered to be secondary to MM
8. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the ICF
9. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she will participate in the study or confounds the ability to interpret data from the study
10. Subjects with any clinical condition that would affect study's outcome
11. Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study, except of the clinical trials that implicate drugs of supportive treatment | 3,530 |
Study Objectives
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
OTHER: TACE, OTHER: TACE+ RTC
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Age ≥ 18 years of age
* ECOG 0-1
* life expectancy ≥ 6 months
* Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients
* Maximum lesion size ≤ 9 cm
* Non-eligible for surgery or percutaneous therapy
* Premature Child-Pugh A or B (7 points for the Child-Pugh score)
* AST and ALT \< 7 x UNL
* Technical possibility of conformational external radiotherapy
* Technical possibility of TACE
* All the tumor mass must be able to be treated by TACE
* Written consent signed by the patient
* Patients affiliated to a social security system
Exclusion Criteria:
* Metastatic illness
* Minimal lesion size ≤ 5 mm
* Non controlled viral replication B
* History of radiotherapy at abdominal level
* Subjects capable of procreating without efficient contraception
* pregnancy or nursing female patient
* Contraindication of TACE or external conformational radiotherapy
* Any other concomitant experimental treatment
* Contraindication of Doxorubicin
* Patients who are unable to respect enslaving respiratory constraints if used by sites
* Patients who are unable to understand information and to follow protocol instructions | 17,183 |
Study Objectives
Confocal laser endomicroscopy (CLE) is a novel and highly promising imaging method for that allows in vivo imaging of the mucosal layer at resolution of approximately 1 micron. Cellular and sub-cellular structures as well as capillaries and single red blood cells can be visualized. CLE is now well established as a highly accurate method for distinguishing neoplasia in the gastrointestinal tract lumen via endoscopy. A major new breakthrough is the development of sub-millimeter CLE probes that can be passed via an image guided needle (nCLE) into solid organs and cysts.
It is hypothesized that nCLE will help distinguish the benign, premalignant and malignant cystic lesions of pancreas by visualizing the cellular lining of the cysts, thereby, avoiding unnecessary surgery in patient with benign cysts and guiding to early and effective surgical removal of high risk neoplastic lesions.
A prototype minimal risk nCLE system has been developed that can be passed via standard endoscopic ultrasound needles into the pancreas but FDA clearance for in vivo use is not expected until late 2010. The investigators propose to evaluate this prototype nCLE system in vivo during endoscopic ultrasound (EUS), as an initial pilot study.
Conditions: Pancreatic Cysts
Intervention / Treatment:
PROCEDURE: Endoscopic Ultrasound (EUS)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients undergoing endoscopic ultrasound for evaluation of pancreatic cysts (including pseudocysts and suspected pancreatic cystic neoplasms) in the gastrointestinal (GI) lab at Mayo Clinic Jacksonville.
Exclusion Criteria:
* Unwilling/unable to consent;
* Solid pancreatic mass on computerized axial tomography/magnetic resonance (CT/MR);
* Allergy to Fluorescein;
* Pregnancy. | 14,403 |
Study Objectives
MR prostate exam is essential for the diagnosis, workup and follow-up of prostate cancer. It allows to detect subclinical prostate cancer following an increase in the level of PSA. The investigators can score the lesion according to the PIRADS classification and obtain an estimate of lesion malignancy. To perform this classification, T2 and DWI sequences are essential.
Detection and characterization of malignant lesion is important to address appropriate patient care pathway. The purpose of this project is to evaluate novel deep learning (DL) T2-weighted TSE (T2DL) and Diffusion (DWIDL) sequences for prostate MR exam and investigate its impact on diagnostic, examination time, image quality, and PI-RADS classification compared to standard T2-weighted TSE (T2S) and standard Diffusion (DWIS) sequences.
Conditions: Prostate Cancer
Intervention / Treatment:
OTHER: MR prostate exam
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age ≥ 18 ans
* Healthy subject without history of hepatic disease
* Patient addressed for an prostate MRI
* Ability to give consent
Exclusion Criteria:
* claustrophobia,
* major obesity (\>140 kg),
* Patient under guardianship or curators
* Age \< 18 years,
* Women,
* History of prostatectomy or irradiation of the prostate
* any contraindication to MRI exam | 10,351 |