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Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma Clinical research trials and Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma. Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma clinical trial. Human subjects often receive the most effective healthcare possible for their Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma  Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
For Condition: stage 3 melanoma
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa plus combination chemotherapy and interleukin-2 is more effective than interferon alfa alone in treating patients with melanoma. PURPOSE: Randomizedphase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.
Details: OBJECTIVES: - Compare the efficacy of postoperative adjuvant therapy with interferon alfa-2b (IFN-A) administered subcutaneously with or without IV induction vs concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A and IL-2 and in melanoma patients with regional lymph node metastases that have been surgically resected. - Determine the relative toxic effects associated with adjuvant therapy with IFN-A and concurrent biochemotherapy including cisplatin, vinblastine, DTIC, IFN-A, and IL-2 and their effect on the quality of life. - Determine the prognostic value of detection of melanoma cells in the peripheral blood using RT/PCR for tyrosinase mRNA. OUTLINE: This is a randomized study. All patients are stratified according to prognostic factors. Patients are randomly allocated to 1 of 2 treatment options. Treatment 1 uses interferon alfa-2b (IFN-A) therapy, and treatment 2 includes adjuvant biochemotherapy. Patients who are randomized to IFN-A will be further stratified and randomized to one of two interferon schedules. - Schedule A: IV IFN-A induction 5 times a week for 4 weeks followed by subcutaneous IFN-A maintenance 3 times a week for 48 weeks. - Schedule B: Subcutaneous IFN-A 3 times a week for 52 weeks. Adjuvant biochemotherapy begins immediately after registration on the study. Cisplatin is given IV on days 1-4; vinblastine is given IVPB on days 1-4; dacarbazine (DTIC) is given IVPB on day 1; IFN-A is given subcutaneously on days 1-5; IL-2 is given by continuous infusion for a total of 96 hours on days 1-4. Each course of therapy is repeated every 21 days for 4 courses. Patients receiving adjuvant radiotherapy will start adjuvant systemic therapy within 8 weeks from lymphadenectomy and a week after completion of and recovery from radiotherapy. PROJECTED ACCRUAL: A total of 200 patients (100 patients in each arm) will be entered.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 10 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically diagnosed malignant melanoma with regional lymph node metastases - Undergone complete lymph node dissection and free of any residual tumor - No greater than 90 days from diagnosis of regional lymph nodes metastases - No distant or resected in-transit metastases PATIENT CHARACTERISTICS: Age: - 10 to 66 - 66 to 70 if in excellent physical condition Performance status: - 0-2 Life expectancy: - At least 12 months Hematopoietic: - Hemoglobin greater than 10 g/dL - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.2 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Other: - No serious intercurrent illness that would compromise tolerance of therapy and long term survival - Must be able to participate in follow up for minimum of 5 years - No second malignancy except: - In situ cervical cancer - Basal or squamous skin cancer - Must be able to physically and emotionally tolerate biochemotherapy - No history of pulmonary or cardiac dysfunction, e.g., cardiac rhythm disturbance, congestive heart failure, coronary bypass, or impaired cardiac ejection fraction PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy with interferon or IL-2 - No concurrent immunomodulators Chemotherapy: - No prior chemotherapy Endocrine therapy: - No concurrent steroids Radiotherapy: - Prior adjuvant local radiotherapy allowed for head and neck Surgery: - No greater than 8 weeks after definitive surgery for lymph node metastases Other: - No concurrent nonsteroid anti-inflammatory drugs, or other prostaglandin synthetase inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AgopBedikian, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000065188; MDA-ID-95196,MDA-DM-95196,NCI-G96-1089
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002882
Other Stage 3 Melanoma Studies:
1. Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
2. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
5. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other stage 3 melanoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Interferon alfa With or Without Combination Chemotherapy Plus Interleukin-2 in Treating Patients With Melanoma
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