ABT-510 in Treating Patients With Metastatic Melanoma

NCT ID: NCT00602199

Last Updated: 2011-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-06-30

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.

Detailed Description

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.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ABT-510

Intervention Type: DRUG

immunoenzyme technique

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Svetomir Markovic, MD, PhD

Role: STUDY_CHAIR

Mayo Clinic

References

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.

Reference Type: RESULT

PMID: 17551310 (View on PubMed)

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC0375

Identifier Type: OTHER

Identifier Source: secondary_id

1439-04

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000582475

Identifier Type: -

Identifier Source: org_study_id