Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic malignant melanoma

  • Unresectable stage III OR stage IV disease
  • Ocular, mucosal, and cutaneous melanoma allowed

• Measurable disease

  • Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
  • Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies

• No more than 2 symptomatic hemorrhagic lesions in the brain

  • No hemorrhagic lesion(s) greater than 1 cm in diameter

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 2 times ULN
• Alkaline phosphatase no greater than 2 times ULN
• Lactic dehydrogenase no greater than 2 times ULN

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• No history of severe cardiovascular disease
• No myocardial infarction within the past 6 months
• No unstable angina
• No New York Heart Association class III or IV congestive heart failure
• No ventricular arrhythmia
• No uncontrolled arrhythmia

Gastrointestinal

• No frequent vomiting
• No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
• HIV negative
• No AIDS-related illness
• No serious infection requiring IV antibiotics
• No other uncontrolled medical illness that would preclude study participation

• No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:

  • Detected incidentally at transurethral resection of the prostate (TURP)
  • Comprises less than 5% of resected tissue
  • Prostate-specific antigen normal since TURP

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 weeks since prior immunotherapy or biologic therapy
• No concurrent immunotherapy

Chemotherapy

• No prior systemic chemotherapy for melanoma
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior focused radiotherapy for brain metastases
• At least 3 weeks since prior radiosurgery
• At least 4 weeks since prior whole brain radiotherapy
• At least 3 weeks since prior interstitial brachytherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 3 weeks since prior surgery for brain metastases
• At least 3 weeks since prior surgery requiring general anesthesia

Other

• Recovered from all prior therapies