A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic melanoma

- Bidimensionally measurable disease by MRI, CT scan, or chest x-ray

- No active brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 12 weeks

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 8.5 g/dL

Hepatic:

- PT/PTT normal

- Bilirubin no greater than 1.5 mg/dL

- SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No uncompensated coronary artery disease by electrocardiogram or physical exam

- No myocardial infarction or severe or unstable angina within the past 6 months

- No deep venous thrombosis within the past 3 months

- No arterial thrombosis within the past 6 months

Pulmonary:

- No pulmonary embolism within the past 6 months

Other:

- HIV negative

- No active infection

- No medical, psychological, or social problem that would preclude study participation

- No history of gastrointestinal disorder that would interfere with absorption or
swallowing of study medication

- No emotional disorder or substance abuse

- No diabetes mellitus with severe peripheral vascular disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception for 4 weeks before,
during, and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than 1 prior biologic regimen

- No concurrent biologic response modifiers

- No concurrent hematopoietic growth factor support

- Concurrent epoetin alfa allowed

Chemotherapy:

- No concurrent cytotoxic agents

Endocrine therapy:

- No concurrent anticancer hormonal therapy except megestrol acetate for appetite
stimulation

Radiotherapy:

- No prior large field radiotherapy to more than 20% total bone marrow

- No concurrent radiotherapy

Surgery:

- At least 14 days since major surgery

- No prior major upper gastrointestinal surgery

Other:

- No other concurrent investigational therapy