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

Melanoma Clinical Trial

Official title:

Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099970
• Other study ID #: M200-1203
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2004
• Last updated: August 2, 2008
• Start date: December 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2008
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastases

Intervention

Drug:
• M200 (volociximab) in Combination with Dacarbazine (DTIC)

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham-Comprehensive Cancer Ctr.	Birmingham	Alabama
United States	MD Anderson Cancer Center	Houston	Texas
United States	UCLA School of Medicine	Los Angeles	California
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Cancer Institute Medical Group, Inc.	Santa Monica	California
United States	Palmetto Hematology Oncology, P.C.	Spartanburg	South Carolina
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
PDL BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a confirmed tumor response at any time during the study.
Secondary	Time to disease progression
Secondary	Duration of tumor response
Secondary	Pharmacokinetics (PK)
Secondary	Immunogenicity