Fotemustine in Treating Patients With Metastatic Melanoma

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