A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed malignant cutaneous melanoma

- Unresectable, stage IV disease

- Unknown primary allowed

- Measurable or non-measurable disease

- If all known sites of disease are within a previously irradiated port, disease
progression must be clearly demonstrated

- No brain metastases by CT scan or MRI within the past 42 days

- Prior brain metastasis allowed provided both of the following criteria are met:

- Completely resected and free of disease

- Treated with whole brain radiotherapy and completed treatment at least 28
days ago

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL (transfusions allowed)

Hepatic

- Bilirubin ≤ 3 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks before,
during, and for 4 weeks after study participation

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission

- No history of allergic reaction to dacarbazine

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior thalidomide for stage IV disease

- At least 28 days since prior biological therapy

- At least 28 days since prior immunotherapy

- At least 28 days since prior adjuvant interferon alfa

Chemotherapy

- No prior temozolomide or dacarbazine for stage IV disease

- At least 28 days since prior chemotherapy

Endocrine therapy

- At least 28 days since prior hormonal therapy

Radiotherapy

- See Disease Characteristics

- At least 28 days since prior radiotherapy

Surgery

- See Disease Characteristics

- At least 28 days since prior surgery for primary and stage IV disease

Other

- No more than 1 prior systemic therapy regimen for stage IV disease

- At least 28 days since other prior systemic therapy