Clinical trial NCT00623766
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Start date: 2008-07-01; Completion date: 2012-10-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.

Detailed description:

Arms: arm 1: Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24. arm 2: Participants who were dependent on corticosteroid therapy received ipilimumab, 10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.
Interventions: intervention 1: Ipilimumab intervention 2: Corticosteroid: Betamethasone intervention 3: Corticosteroid: Dexamethasone intervention 4: Corticosteroid: Fludrocortisone intervention 5: Corticosteroid: Hydrocortisone intervention 6: Corticosteroid: Meprednisone intervention 7: Corticosteroid: Methylprednisolone intervention 8: Corticosteroid: Prednisolone intervention 9: Corticosteroid: Prednisone intervention 10: Corticosteroid: Triamcinolone
Intervention descriptions: intervention 1: 10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance intervention 2: 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 intervention 3: 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 intervention 4: 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 intervention 5: 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 intervention 6: 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 intervention 7: 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 intervention 8: 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 intervention 9: 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 intervention 10: 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

Protocol documents: