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

Sponsor

PDL BioPharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00099970

Collaborator

(none)

Enrollment

Locations

14.9

Duration (Months)

5.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2004

Study Completion Date :

Mar 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham-Comprehensive Cancer Ctr.	Birmingham	Alabama	United States	35294-3300
2	Arizona Cancer Center	Tucson	Arizona	United States	85724
3	UCLA School of Medicine	Los Angeles	California	United States	90095
4	Cancer Institute Medical Group, Inc.	Santa Monica	California	United States	90404
5	University of Pittsburgh	Pittsburgh	Pennsylvania	United States
6	Palmetto Hematology Oncology, P.C.	Spartanburg	South Carolina	United States	29303
7	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