Spots Global Cancer Trial Database for Fotemustine in Treating Patients With Metastatic Melanoma

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Trial Identification

Brief Title: Fotemustine in Treating Patients With Metastatic Melanoma

Official Title: Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma

Study ID: NCT00560118

Conditions

Melanoma (Skin)

Interventions

fotemustine

gene expression analysis

polymerase chain reaction

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.

Detailed Description: OBJECTIVES: Primary * Assess the relationship between MGMT expression and response to fotemustine in patients with metastatic malignant melanoma. Secondary * Establish a value for MGMT expression below which fotemustine has a strong probability of effectiveness. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8, and 15. Beginning 5 weeks later, patients achieving stable or objective response receive maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6 courses. Tissue samples are collected at baseline to assess level of MGMT expression by PCR. After completion of study treatment, patients are followed every 2 months.