Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Semaxinib; Thalidomide

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