Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

PHASE2CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

October 31, 2012

Conditions
Melanoma
Interventions
DRUG

Ipilimumab

10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance

DRUG

Corticosteroid: Betamethasone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone

DRUG

Corticosteroid: Dexamethasone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with dexamethasone

DRUG

Corticosteroid: Fludrocortisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with fludrocortisone

DRUG

Corticosteroid: Hydrocortisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with hydrocortisone

DRUG

Corticosteroid: Meprednisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with meprednisone

DRUG

Corticosteroid: Methylprednisolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with methylprednisolone

DRUG

Corticosteroid: Prednisolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisolone

DRUG

Corticosteroid: Prednisone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with prednisone

DRUG

Corticosteroid: Triamcinolone

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with triamcinolone

Trial Locations (14)

10065

Memorial Sloan Kettering Cancer Center, New York

10466

Local Institution, The Bronx

37232

Vanderbilt-Ingram Cancer Ctr, Nashville

46202

Indiana University Cancer Center, Indianapolis

60068

Oncology Specialists, S.C., Park Ridge

60153

Loyola University Medical Center, Maywood

85259

Mayo Clinic Arizona, Scottsdale

90025

The Angeles Clinic & Research Institute, Los Angeles

97213

Providence Portland Med Ctr, Portland

91010-3000

City Of Hope, Duarte

06520

Yale University School Of Medicine, New Haven

02215

Dana Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

98109-1023

Seattle Cancer Care Alliance, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medarex

INDUSTRY

lead

Bristol-Myers Squibb

INDUSTRY