SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated

Study Overview
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Brief Summary
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SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated

Detailed Description
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PRIMARY OBJECTIVES: I. Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416. II. Determine the toxicity of SU5416 in this patient population. III. Determine the median and overall survival and time to progression in these patients receiving this treatment. OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24 months.

Official Title
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A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Conditions
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Recurrent Melanoma, Stage IV Melanoma

Intervention / Treatment
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* Drug: semaxanib
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed melanoma with documented metastatic disease In transit metastases allowed Lesion accessible for biopsy Measurable disease Greater than 20 mm by conventional techniques ORgreater than 10 mm by spiral CT Documented progressive disease by radiologic study or physical examination Known history of CNS metastasis who have had treatment, are neurologicallystable, and do not require intravenous antibiotics or anticonvulsants eligibleprovided oral steroids are not required and brain scan (CT or MRI) showsabsence of active or residual disease If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required Performance status - WHO 0-2 At least 12 weeks WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within past 3 months No pulmonary embolism within past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other significant uncontrolled underlying medical or psychiatric illness No serious active infections No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel No other concurrent chemotherapy No other concurrent investigational antineoplastic drugs See Disease Characteristics No prior radiotherapy to only site of measurable disease At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy No greater than 1 prior therapy for metastatic disease At least 4 weeks since prior 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: Treatment (semaxanib)<br>Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. | Drug: semaxanib<br>* Given IV<br>* Other names: Sugen 5416;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate |  | Up to 3 years | 
| Overall response rate (complete and partial responses) |  | Up to 3 years | 
| Maintenance of stable disease |  | Up to 3 years | 
| Treatment toxicity |  | Up to 4 weeks post treatment | 
| Time to progression | Kaplan-Meier estimates will be calculated. | Up to 3 years | 
| Survival | Kaplan-Meier estimates will be calculated. | Up to 3 years |