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

This study has been completed.
Sponsor:
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00099970
First received: December 21, 2004
Last updated: August 2, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Melanoma
Metastases
Drug: M200 (volociximab) in Combination with Dacarbazine (DTIC)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

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

Secondary Outcome Measures:
  • Time to disease progression
  • Duration of tumor response
  • Pharmacokinetics (PK)
  • Immunogenicity

Estimated Enrollment: 40
Study Start Date: December 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099970

Locations
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.
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00099970     History of Changes
Other Study ID Numbers: M200-1203
Study First Received: December 21, 2004
Last Updated: August 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Solid tumors
Metastatic melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014