Clinical trial NCT00099970: Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy
Official title: Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Metastases
Keywords: Solid tumors
Metastatic melanoma
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2004-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with a confirmed tumor response at any time during the study.
Secondary outcomes:
measure: Time to disease progression
measure: Duration of tumor response
measure: Pharmacokinetics (PK)
measure: Immunogenicity
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham-Comprehensive Cancer Ctr.
state: Alabama
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Santa Monica
country: United States
facility: Cancer Institute Medical Group, Inc.
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Spartanburg
country: United States
facility: Palmetto Hematology Oncology, P.C.
state: South Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cancer Institute Medical Group, Inc.
name: Steven J. O'Day, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: John Kirkwood, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Agop Y. Bedikian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Antoni Ribas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Hematology Oncology, P.C.
name: Colin P. Curran, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Andres Forero, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Lee Cranmer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: