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Sponsors and Collaborators: |
Bristol-Myers Squibb Medarex |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00623766 |
To determine if melanoma brain metastases will respond to ipilimumab treatment while being generally well tolerated
Condition | Intervention | Phase |
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Melanoma |
Drug: Ipilimumab Drug: Steroids |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases |
Estimated Enrollment: | 72 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ipilimumab: Experimental |
Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
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Ipilimumab + Steroids: Experimental |
Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Drug: Steroids
Oral, tablets, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion
United States, Arizona | |
Mayo Clinic Arizona | |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
City Of Hope | |
Duarte, California, United States, 91010 | |
The Angeles Clinic & Research Institute, Inc | |
Los Angeles, California, United States, 90025 | |
Ucsf Mount Zion | |
San Francisco, California, United States, 94143 | |
United States, Connecticut | |
Yale University School Of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Illinois | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Oncology Specialists, S.C. | |
Park Ridge, Illinois, United States, 60068 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
North Division Montefiore | |
Bronx, New York, United States, 10466 | |
Mem Sloan-Ket Can Ctr | |
New York, New York, United States, 10021 | |
United States, Oregon | |
Providence Portland Med Ctr | |
Portland, Oregon, United States, 97213 | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Seattle Can Care Alliance | |
Seattle, Washington, United States, 98109 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA184-042 |
Study First Received: | February 19, 2008 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00623766 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Neoplasm Metastasis Nevi and Melanomas Neuroendocrine Tumors Melanoma |