Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: semaxanib
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: semaxanib<br> <br> Drug: thalidomide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma