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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC0375 | Other Identifier | Mayo Clinic Cancer Center | |
| 1439-04 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-510 | Drug | |||
| immunoenzyme technique | Other | |||
| immunohistochemistry staining method | Other | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other | |||
| biopsy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 18-week progression-free survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Measurable disease
No history of or current CNS metastases
No known, presently active carcinomatous meningitis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Svetomir Markovic, MD, PhD | Mayo Clinic | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17551310 | Result | Markovic SN, Suman VJ, Rao RA, Ingle JN, Kaur JS, Erickson LA, Pitot HC, Croghan GA, McWilliams RR, Merchan J, Kottschade LA, Nevala WK, Uhl CB, Allred J, Creagan ET. A phase II study of ABT-510 (thrombospondin-1 analog) for the treatment of metastatic melanoma. Am J Clin Oncol. 2007 Jun;30(3):303-9. doi: 10.1097/01.coc.0000256104.80089.35. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C500617 | NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt |
| D007124 | Immunoenzyme Techniques |
| D007150 | Immunohistochemistry |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
| D015336 | Molecular Probe Techniques |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006651 |
| Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |