interferon alfa with or without combination chemotherapy plus interleukin-2 in treating patients with melanoma

Conditions: Melanoma; Skin Cancer

Summary: 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.

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 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

Keywords: stage iii melanoma