A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV malignant melanoma with measurable and unresectable
disease limited to the central nervous system (CNS)

- Study entry within 14 days of diagnosis of brain metastases

- Recursive partitioning analysis class I or II

- Disease for which no known standard therapy exists that is potentially curative or
proven capable of extending life expectancy

- No meningeal carcinomatosis based on imaging studies or on positive results from CSF
analysis

- No evidence of metastatic disease outside of the CNS

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

Hepatic

- AST no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 3 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent uncontrolled infection

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer treated with local resection only

- No prior allergy or intolerance to dacarbazine

- No hypersensitivity to temozolomide or any of its components

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior biologic therapy

- More than 4 weeks since prior immunotherapy

Chemotherapy

- No prior temozolomide

- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
and recovered

Endocrine therapy

- Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging

Radiotherapy

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 15% of the bone marrow

- No prior radiotherapy to the head and neck area

- No prior radiosurgery

Surgery

- See Radiotherapy