Fotemustine in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Fotemustine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic malignant melanoma, meeting the following criteria:

• Metastatic lymph nodes or skin allowing for surgical resection

• At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• ANC > 2 x 10^9/L

• Platelet count > 100 x 10^9/L

• Transaminases ≤ 2.5 times normal

• Alkaline phosphate ≤ 2.5 times normal

• Total bilirubin normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No severe uncontrolled infection

• No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

• At least 2 weeks since prior adjuvant therapy

• At least 4 weeks since prior radiotherapy

• At least 30 days since prior participation in another clinical trial

• No prior or concurrent prophylactic phenytoin