Melanoma Clinical Trial
Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
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.
Full Description
OBJECTIVES:
I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.
II. Determine the quantitative and qualitative toxic effects of this regimen in these patients.
III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen.
V. Assess disease-free survival at 6 months of patients treated with this regimen.
OUTLINE:
Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Eligibility 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
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There is 1 Location for this study
San Antonio Texas, 78284, United States
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