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

PDL BioPharma

Status and phase

Completed

Phase 2

Conditions

Melanoma

Metastases

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099970

M200-1203

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.