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Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma Clinical research trials and Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma. Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma  Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): St. Luke's Medical Center ,
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastaticmelanoma.
Details: OBJECTIVES: - Determine the safety of interleukin-12-primed activated T cells (12ATC) and temozolomide in patients with metastatic melanoma. - Determine the maximum tolerated dose of 12ATC in this patient population. - Determine the clinical response of patients treated with this regimen. OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC). Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC. Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 patients experience dose-limiting toxicity. Patients are followed weekly for 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic melanoma - No ocular or mucosal melanoma - Must meet one of the following criteria: - Failed standard or salvage therapy - Ineligible for standard therapy due to concurrent illness - Declined standard therapy - Received at least 1 prior therapy for metastatic disease - Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases - No leptomeningeal metastases - At least 1 documented site of bidimensionally measurable disease by MRI or CT scan - Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - No coagulation disorder such as thrombophlebitis Hepatic: - Bilirubin less than 2.0 mg/dL - AST and ALT less than 3 times upper limit of normal (ULN) - Alkaline phosphatase less than 3 times ULN Renal: - Creatinine less than 1.5 times ULN - BUN less than 1.5 times ULN Cardiovascular: - Ejection fraction at least 45% - No active ischemia - No unstable angina - No uncontrolled congestive heart failure Pulmonary: - Normal pulmonary function tests within the past month - FEV1 or FVC more than 65% predicted - No uncontrolled pulmonary embolism Gastrointestinal: - No frequent vomiting - No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) Other: - No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks - No uncontrolled cortical dysfunction - No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality) - No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix - No significant psychiatric disease that would preclude study compliance - No AIDS-related illness - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - See Disease Characteristics Biologic therapy: - More than 1 month since prior biologic therapy or immunotherapy Chemotherapy: - More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - At least 4 weeks since prior steroid therapy or steroid-containing compounds - At least 2 weeks since prior topical or inhaled steroids Radiotherapy: - See Disease Characteristics - More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery Surgery: - At least 1 week since prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnHanson, Study Chair, St. Luke's Medical Center
St. Luke's Medical Center *Recruiting*
Milwaukee, Wisconsin, 53201-2901
United States
Recruiting John Hanson 414-649-5818
Additional Information:
Study ID Numbers: CDR0000068590; NCI-V01-1657,STLMC-IMM-0002
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016055
Other Recurrent Melanoma Studies:
1. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
2. Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
3. PI-88 in Treating Patients With an Advanced Malignancy (Cancer) or Stage IV Melanoma
4. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
5. Vaccine Therapy in Treating Patients With Stage IV Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
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