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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099970
Recruitment Status : Completed
First Posted : December 22, 2004
Last Update Posted : August 5, 2008
Information provided by:
Facet Biotech

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Metastases Drug: M200 (volociximab) in Combination with Dacarbazine (DTIC) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
Study Start Date : December 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Proportion of patients with a confirmed tumor response at any time during the study.

Secondary Outcome Measures :
  1. Time to disease progression
  2. Duration of tumor response
  3. Pharmacokinetics (PK)
  4. Immunogenicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00099970

United States, Alabama
University of Alabama at Birmingham-Comprehensive Cancer Ctr.
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
Cancer Institute Medical Group, Inc.
Santa Monica, California, United States, 90404
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Palmetto Hematology Oncology, P.C.
Spartanburg, South Carolina, United States, 29303
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
PDL BioPharma, Inc.
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: Antoni Ribas, MD University of California, Los Angeles
Principal Investigator: Colin P. Curran, M.D. Palmetto Hematology Oncology, P.C.
Principal Investigator: Andres Forero, M.D. University of Alabama at Birmingham
Principal Investigator: Lee Cranmer, M.D. University of Arizona Identifier: NCT00099970     History of Changes
Other Study ID Numbers: M200-1203
First Posted: December 22, 2004    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008

Keywords provided by Facet Biotech:
Solid tumors
Metastatic melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs