Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II

Inclusion Criteria

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