chemotherapy followed by biological therapy in treating patients with stage iv melanoma that cannot be treated with surgery

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. combining chemotherapy with biological therapies may kill more tumor cells. purpose: phase ii trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage iv melanoma that cannot be treated with surgery.

objectives: * determine the response rate, time to progression, and survival of patients with unresectable stage iv melanoma treated with temozolomide followed by sargramostim (gm-csf), interleukin-2, and interferon alfa. * determine the safety and tolerability of this regimen in this patient population. * determine the changes in quality of life over time in patients treated with this regimen. outline: this is a multicenter study. patients receive oral temozolomide on days 1-5, and sargramostim (gm-csf), interleukin-2, and interferon alfa subcutaneously on days 6-17. treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion. quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study. patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter. projected accrual: a total of 14-30 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed unresectable stage iv melanoma * measurable metastatic disease * no uncontrolled brain metastases patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * more than 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot and sgpt no greater than 3 times uln * alkaline phosphatase no greater than 3 times uln renal: * bun no greater than 1.5 times uln * creatinine no greater than 1.5 times uln cardiovascular: * no significant cardiovascular disease other: * no non-malignant systemic disease * no acute infection requiring iv antibiotics * no alcohol or substance abuse * no other condition, disease, or history of other illness that would preclude study participation * no hypersensitivity, allergic reactions, or intolerance to study drugs * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy * no prior interleukin-2 * no other concurrent immunotherapy * no concurrent investigational vaccines or immunomodulatory agents * no other concurrent growth factors chemotherapy: * at least 4 weeks since prior chemotherapy * no prior temozolomide * no other concurrent anticancer chemotherapy endocrine therapy: * no concurrent steroids (including corticosteroids) radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * see disease characteristics * at least 3 weeks since prior major surgery other: * at least 30 days since prior immune-based therapy * no concurrent participation in other clinical trials with investigational drugs * no other concurrent anticancer drugs * no concurrent immunosuppressive therapy * no concurrent levamisole or cimetidine

Keywords: stage iv melanoma recurrent melanoma