ABT-510 in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients with metastatic melanoma.

Detailed Description
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OBJECTIVES: Examine the safety profile of ABT-510 in patients with metastatic malignant melanoma. Examine the antitumor activity (i.e., time to progression and response rates) in patients treated with ABT-510. Determine the pharmacodynamic effects of ABT-510 and its potential impact on immune cell function in these patients. OUTLINE: Patients receive ABT-510 subcutaneously twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. Samples are evaluated for EC enumeration, expression profiling, circulating tumor cell quantification, analysis of T-cell functions (i.e., immunophenotyping for NK-, T- and B-cell phenotypes as well as ELISPOT analysis against common environmental pathogens and T cell spectratyping), and angiogenesis bioassays. Patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (CD38 and von Willebrand Factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5. After completion of study treatment, patients are followed every 3 months for up to 5 years.

Official Title
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A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: ABT-510
* Other: immunoenzyme technique
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Other: pharmacological study
* Procedure: biopsy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Stage IV disease No known potentially curative standard therapy that exists or is proven capable of extending life expectancy Measurable disease No history of or current CNS metastases MRI of the brain to confirm absence of CNS metastases within the past 28 days is required No known, presently active carcinomatous meningitis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 6 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) AST ≤ 3 times ULN Creatinine ≤ 2.5 times ULN Hemoglobin ≥ 9.0 g/dL Prothrombin time normal Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled or current infection No New York Heart Association class III-IV heart disease No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis) No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event No uncontrolled hypertension No history of stroke or other CNS bleeding events (e.g., aneurysms) PRIOR CONCURRENT THERAPY: At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas) At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery No concurrent anticoagulation therapy or antiplatelet therapy No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABT-510|nan|
|Other: immunoenzyme technique|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Other: pharmacological study|nan|
|Procedure: biopsy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18-week progression-free survival rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate as defined by RECIST criteria |  |  | 
| Overall survival time |  |  | 
| Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment |  |  | 

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