ABT-510 in Treating Patients With Metastatic Melanoma

NCT00602199 | Completed Phase 2

• 4 other identifiers: CDR0000582475P30CA015083MC03751439-04
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• 18-week progression-free survival rate

Secondary Outcomes (3)

• 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

Interventions

ABT-510 DRUG

immunoenzyme technique OTHER

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Stage IV disease * No known potentially curative standard therapy that exists or is proven capable of extending life expectancy * Measurable disease * No history of or current CNS metastases * MRI of the brain to confirm absence of CNS metastases within the past 28 days is required * No known, presently active carcinomatous meningitis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 6 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) * AST ≤ 3 times ULN * Creatinine ≤ 2.5 times ULN * Hemoglobin ≥ 9.0 g/dL * Prothrombin time normal * Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up * Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled or current infection * No New York Heart Association class III-IV heart disease * No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis) * No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event * No uncontrolled hypertension * No history of stroke or other CNS bleeding events (e.g., aneurysms) PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas) * At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery * No concurrent anticoagulation therapy or antiplatelet therapy * No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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.

  PMID: 17551310 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt; Immunoenzyme Techniques; Immunohistochemistry; Biopsy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoassay; Immunologic Techniques; Investigative Techniques; Molecular Probe Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Study Officials

• Svetomir Markovic, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 28, 2008
• Study Start: November 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: May 16, 2011

Record last verified: 2011-05