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| Sponsor: | Bristol-Myers Squibb |
|---|---|
| Information provided by: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00050102 |
Purpose
The objectives of this study are to determine the safety and activity profile of multiple doses of MDX-010, and to determine the whether the addition of cytotoxic chemotherapy (decarbazine [DTIC]) can augment the effects of MDX-010 in patients with chemotherapy naïve metastatic melanoma with a tolerable toxicity profile.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Treatment of metastatic melanoma |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Study Comparing MDX-010 (CTLA-4) Alone or in Combination With DTIC in the Treatment of Patients With Chemotherapy Naїve Metastatic Melanoma. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Patients who exhibit any of the following conditions at screening will not be eligible for admission into the study:
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Pacific Shores Medical Group | |
| Long Beach, California, United States, 90813 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Cancer Institute Medical Group | |
| Santa Monica, California, United States, 90404 | |
| Northern California Melanoma Center | |
| San Francisco, California, United States, 94109 | |
| United States, Indiana | |
| Indiana Oncology/ Hematology Consultants | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, North Carolina | |
| Piedmont Oncology Specialists | |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Texas | |
| Joe Arrington Cancer. Research & Treatment Center | |
| Lubbock, Texas, United States, 79410 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
| Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
| Study ID Numbers: | MDX010-08, CA184-013 |
| Study First Received: | November 21, 2002 |
| Last Updated: | February 3, 2010 |
| ClinicalTrials.gov Identifier: | NCT00050102 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |