ABT-510 in Treating Patients With Metastatic Melanoma
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.
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510|
- 18-week progression-free survival rate [ Designated as safety issue: No ]
- Objective response rate as defined by RECIST criteria [ Designated as safety issue: No ]
- Overall survival time [ Designated as safety issue: No ]
- Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment [ Designated as safety issue: No ]
|Study Start Date:||November 2004|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602199
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|