Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

August 2, 2008 updated by: PDL BioPharma, Inc.

Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo

This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham-Comprehensive Cancer Ctr.
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • Santa Monica, California, United States, 90404
        • Cancer Institute Medical Group, Inc.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology Oncology, P.C.
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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

Inclusion Criteria:

  • Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa).
  • Measurable disease according to Response Criteria for Solid Tumors (RECIST).
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1.
  • Estimated survival is greater or equal to 4 months.
  • Negative pregnancy test (women of childbearing potential only).
  • Pretreatment laboratory levels that meet specific criteria.
  • Signed informed consent, including permission to use protected health information.

Exclusion Criteria:

  • Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies.
  • Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens.
  • Known sensitivity to murine proteins or chimeric antibodies or other components of the product.
  • Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer).
  • Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200.
  • Documented central nervous system (CNS) tumor or CNS metastasis.
  • History of thromboembolic events and bleeding disorders within the past year.
  • Medical conditions that may be exacerbated by bleeding.

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients with a confirmed tumor response at any time during the study.

Secondary Outcome Measures

Outcome Measure
Time to disease progression
Duration of tumor response
Pharmacokinetics (PK)
Immunogenicity

Collaborators and Investigators

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

Sponsor

PDL BioPharma, Inc.

Investigators

  • Principal Investigator: Andres Forero, M.D., University of Alabama at Birmingham
  • Principal Investigator: Steven J. O'Day, M.D., Cancer Institute Medical Group, Inc.
  • Principal Investigator: John Kirkwood, M.D., University of Pittsburgh
  • Principal Investigator: Agop Y. Bedikian, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Colin P. Curran, M.D., Palmetto Hematology Oncology, P.C.
  • Principal Investigator: Lee Cranmer, M.D., University of Arizona

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

December 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

December 21, 2004

First Submitted That Met QC Criteria

December 21, 2004

First Posted (Estimate)

December 22, 2004

Study Record Updates

Last Update Posted (Estimate)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 2, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M200-1203

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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