IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Melanoma
Interventions
DRUG

Ipilimumab

"Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.~Phase II dose: Maximum tolerated dose (MTD) from Phase I."

DRUG

Temozolomide

200 mg/m\^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).

DRUG

Cisplatin

25 mg/m\^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).

DRUG

Interferon Alfa-2b

5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

DRUG

Interleukin-2

9 million IU/m\^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER