S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

OBJECTIVES:

• Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide.
• Determine the objective response (confirmed and unconfirmed complete response and partial response) in patients with measurable disease treated with this regimen.
• Determine the overall survival of patients treated with this regimen.
• Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at week 9, every 2 months until disease progression, and then every 6 months until 3 years from study entry.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.

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