ABT-510 in Treating Patients With Metastatic Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00602199
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-12
• Study First Posted: 2008-01-28
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-13
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
18-week progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
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