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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M200 (volociximab) in Combination with Dacarbazine (DTIC) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a confirmed tumor response at any time during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | ||
| Duration of tumor response | ||
| Pharmacokinetics (PK) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham-Comprehensive Cancer Ctr. | Birmingham | Alabama | 35294-3300 | United States | ||
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| Immunogenicity |
| Arizona Cancer Center |
| Tucson |
| Arizona |
| 85724 |
| United States |
| UCLA School of Medicine | Los Angeles | California | 90095 | United States |
| Cancer Institute Medical Group, Inc. | Santa Monica | California | 90404 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
| Palmetto Hematology Oncology, P.C. | Spartanburg | South Carolina | 29303 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C516631 | volociximab |
| D003606 | Dacarbazine |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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