NCT00602199

ABT-510 in Treating Patients With Metastatic Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	ABT-510
OTHER	immunoenzyme technique
OTHER	immunohistochemistry staining method
OTHER	laboratory biomarker analysis
OTHER	pharmacological study
PROCEDURE	biopsy

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2008-01-28
• Last updated: 2011-05-16