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

NCT ID: NCT00099970

Last Updated: 2008-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma Metastases

Keywords

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Solid tumors Metastatic melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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M200 (volociximab) in Combination with Dacarbazine (DTIC)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PDL BioPharma, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Steven J. O'Day, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute Medical Group, Inc.

John Kirkwood, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Agop Y. Bedikian, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Antoni Ribas, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Colin P. Curran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Palmetto Hematology Oncology, P.C.

Andres Forero, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Lee Cranmer, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Alabama at Birmingham-Comprehensive Cancer Ctr.

Birmingham, Alabama, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

Cancer Institute Medical Group, Inc.

Santa Monica, California, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Palmetto Hematology Oncology, P.C.

Spartanburg, South Carolina, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M200-1203

Identifier Type: -

Identifier Source: org_study_id