Spots Global Cancer Trial Database for Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

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Trial Identification

Brief Title: Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

Official Title: Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial

Study ID: NCT00014092

Conditions

Melanoma (Skin)

Interventions

aldesleukin

recombinant interferon alfa

sargramostim

temozolomide

Study Description

Brief 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.

Detailed Description: 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.