Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

OBJECTIVES:

• Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide.
• Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen.
• Determine the quantitative and qualitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV malignant melanoma

• Surgically incurable disease
• Measurable or evaluable disease
• No brain metastases by CT scan or MRI

• Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy
• Must have received 1, and only 1, prior systemic therapy for metastatic disease

• Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy

PATIENT CHARACTERISTICS:

Age:

• Adult

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 75,000/mm^3

Hepatic:

• SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)
• Bilirubin no greater than ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study
• HIV negative
• No AIDS or HIV-1-associated complex
• No other serious illness
• No serious active infections
• No sensory neuropathy greater than grade 1
• No prior seizures or concurrent potential risk factors for the development of seizures
• No other prior 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 currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics
• At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered
• No concurrent filgrastim (G-CSF)
• No other concurrent biologic therapy

Chemotherapy:

• See Disease Characteristics
• At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered
• No concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics
• At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered
• No concurrent hormonal therapy
• No concurrent systemic steroids (including creams)

Radiotherapy:

• See Disease Characteristics
• At least 21 days since prior radiotherapy and recovered
• Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 21 days since prior surgery for primary or metastatic disease and recovered
• No concurrent surgery

Other:

• At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered
• At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered
• No other concurrent therapy
• No other concurrent investigational drugs
• No concurrent immunosuppressive medications
• Concurrent antihistamines allowed if no alternative medication available