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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Metastases

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients with a confirmed tumor response at any time during the study.

Principal Investigator

Steven J. O'Day, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute Medical Group, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

M200-1203

NCT ID:

NCT00099970

Start Date:

December 2004

Completion Date:

March 2006

Related Keywords:

  • Melanoma
  • Metastases
  • Solid tumors
  • Metastatic melanoma
  • Melanoma
  • Neoplasm Metastasis

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
UCLA School of MedicineLos Angeles, California  900121973
University of PittsburghPittsburgh, Pennsylvania  15261
Cancer Institute Medical Group, Inc.Santa Monica, California  90404
University of Alabama at Birmingham-Comprehensive Cancer Ctr.Birmingham, Alabama  35294-3300
Palmetto Hematology Oncology, P.C.Spartanburg, South Carolina  29303