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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602199 |
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 | Intervention | Phase |
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Melanoma (Skin) |
Drug: ABT-510 Procedure: biopsy Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Anti-Angiogenesis Therapy for Metastatic Melanoma Using ABT-510 |
Estimated Enrollment: | 42 |
Study Start Date: | November 2004 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
No history of or current CNS metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Svetomir Markovic, MD, PhD | Mayo Clinic |
Investigator: | James N. Ingle, MD | Mayo Clinic |
Investigator: | Edward T. Creagan, MD | Mayo Clinic |
Investigator: | Judith S. Kaur, MD | Mayo Clinic |
Investigator: | Lori A. Erickson, MD | Mayo Clinic |
Investigator: | Henry C. Pitot, MD | Mayo Clinic |
Investigator: | Gary A. Croghan, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000582475, MAYO-MC0375 |
Study First Received: | January 11, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00602199 |
Health Authority: | United States: Federal Government |
stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |