NCT00099970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

December 21, 2004

Last Update Submit

August 2, 2008

Conditions

MelanomaMetastases

Keywords

Solid tumorsMetastatic melanoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • Time to disease progression

  • Duration of tumor response

  • Pharmacokinetics (PK)

  • Immunogenicity

Interventions

M200 (volociximab) in Combination with Dacarbazine (DTIC)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham-Comprehensive Cancer Ctr.

Birmingham, Alabama, 35294-3300, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Cancer Institute Medical Group, Inc.

Santa Monica, California, 90404, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Palmetto Hematology Oncology, P.C.

Spartanburg, South Carolina, 29303, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

volociximabDacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2004

First Posted

December 22, 2004

Study Start

December 1, 2004

Study Completion

March 1, 2006

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations

US(7)