ABT-510 in Treating Patients With Metastatic Melanoma

May 13, 2011 updated by: Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
18-week progression-free survival rate

Secondary Outcome Measures

Outcome Measure
Overall survival time
Objective response rate as defined by RECIST criteria
Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 12, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000582475
  • P30CA015083 (U.S. NIH Grant/Contract)
  • MC0375 (Other Identifier: Mayo Clinic Cancer Center)
  • 1439-04 (Other Identifier: Mayo Clinic IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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