ABT-510 in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00602199|
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : May 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: ABT-510 Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
- 18-week progression-free survival rate
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602199
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|