HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 29, 2009

Primary Completion Date

June 3, 2014

Study Completion Date

June 3, 2014

Conditions
Brain and Central Nervous System Tumors
Interventions
BIOLOGICAL

HSPPC-96

Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.

DRUG

Temozolomide

Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.

PROCEDURE

Standard Surgical Resection

Patients will undergo standard surgical resection of intracranial tumor

Trial Locations (9)

10032

Columbia University, New York

10549

Northern Westchester Hospital, Mount Kisco

19104

University of Pennsylvania, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

33136

University of Miami, Miami

60611

Northwestern University, Chicago

73104

University of Oklahoma, Oklahoma City

94115

University of California, San Francisco, San Francisco

07652

The Valley Hospital, Paramus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

lead

University of California, San Francisco

OTHER