PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant melanoma, including any of the following:

  • Cutaneous melanoma
  • Ocular melanoma
  • Mucosal melanoma
  • Unidentified primary tumor
• Recurrent or metastatic disease
• Bidimensionally measurable or evaluable disease
• Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT ≤ 2 times ULN

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

• None of the following conditions within the past 3 months:

  • Congestive heart failure
  • Second- or third-degree heart block
  • Myocardial infarction

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
• No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
• No concurrent blood, sperm, or ova donation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy (e.g., interferon) allowed

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 28 days since prior radiotherapy

Surgery

• At least 28 days since prior surgery

Other

• No more than 2 prior systemic treatment regimens for metastatic malignant melanoma