Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed unresectable metastatic melanoma

- Must have asymptomatic brain metastasis that is not amenable to surgery or
stereotactic radiosurgery (gamma knife, Linac)

- Must have concurrent visceral/soft tissue metastases

- At least 1 site of measurable disease (not necessarily the brain metastasis)

- Documented evidence of disease progression defined by 1 of the following conditions:

- More than 25% increase in the size of at least 1 measurable lesion

- Appearance of a new lesion

- A significant increase in the size of nonmeasurable disease

- No neurological symptoms, including signs of elevated intracranial pressure

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

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 10 g/dL

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT less than 3 times ULN

- Alkaline phosphatase less than 3 times ULN

Renal:

- Urea less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Other:

- No frequent vomiting or medical condition (e.g., partial bowel obstruction) that
would interfere with oral medication intake

- No other prior or concurrent malignancy except surgically cured carcinoma in situ of
the cervix or basal cell or squamous cell skin cancer

- No uncontrolled infection

- HIV negative

- No AIDS-related illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychological, familial, sociological, or geographical condition that would
preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior cytokine via isolated limb perfusion for local-regional melanoma allowed

- No other prior cytokine for metastatic melanoma

- No concurrent colony-stimulating factors, including epoetin alfa or filgrastim
(G-CSF)

- No other concurrent immunologic or biologic therapy

Chemotherapy:

- Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed

- No other prior chemotherapy for metastatic melanoma

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent corticosteroids allowed during radiotherapy (arm II only)

- No concurrent hormonal therapy

Radiotherapy:

- See Disease Characteristics

- No other concurrent radiotherapy

Surgery:

- See Disease Characteristics

- Recovered from the effects of any prior major surgery

Other:

- No other concurrent investigational drugs