Expired Study
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Houston, Texas 77030


Purpose:

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: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma.


Study summary:

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.


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


NCT ID:

NCT00002882


Primary Contact:

Study Chair
Agop Y. Bedikian, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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