Spots Global Cancer Trial Database for ABT-510 in Treating Patients With Metastatic Melanoma

Study Description

Brief Summary: 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: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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