Study of Ipilimumab to Treat Melanoma in Patients With Brain Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00623766
First received: February 19, 2008
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
To determine if melanoma brain metastases will respond to ipilimumab treatment while being generally well tolerated
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Ipilimumab Drug: Corticosteroid with Investigator choice |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Phase II Study to Evaluate Tumor Response to Ipilimumab (BMS-734016) Monotherapy in Subjects With Melanoma Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Tumor assessment [ Time Frame: after 12 weeks of first dose and then every 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression free survival - Incidence of MRI defined brain edema [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
- Safety and tolerability of treatment [ Time Frame: Every study visit ] [ Designated as safety issue: Yes ]
- Response of tumor in presence or absence of corticosteroids [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ipilimumab |
Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Other Names:
|
| Experimental: Ipilimumab + Corticosteroid with Investigator choice |
Drug: Ipilimumab
IV, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
Other Names:
Drug: Corticosteroid with Investigator choice
Oral, tablets, 10 mg/kg, every 3 weeks during induction; every 12 weeks during maintenance, 9-12 months depending on response
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Malignant melanoma with measurable brain metastases
- At least one measurable index metastatic brain lesion, with its greatest dimension > 0.5 cm and no larger than 3 cm in diameter, that has not been previously irradiated, and/or at least 2 measurable lesions > 0.3 cm that are visible on contrast-enhanced MRI
- ECOG 0-1
- Stable labs
- Age >/= 16 years
Exclusion
- Auto immune disease, Hepatitis or HIV, other cancer
- Previous treatment with other CTLA-4 agonists, or concurrent IL-2 therapy
- Major surgery within 28 days
- Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623766
Locations
| 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 | |
| Los Angeles, California, United States, 90025 | |
| Local Institution | |
| 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 | |
| Local Institution | |
| 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 Ctr | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided by Bristol-Myers Squibb
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00623766 History of Changes |
| Other Study ID Numbers: | CA184-042 |
| Study First Received: | February 19, 2008 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Melanoma Neoplasm Metastasis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013