Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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