A Phase 2 Multicenter Trial of Autologous Heat Shock Protein-Peptide Vaccine (HSPPC-96) for Recurrent Glioblastoma Multiforme (GBM) Patients Shows Improved Survival Compared to a Contemporary Cohort Controlled for Age, KPS and Extent of Resection

Andrew Thomas Parsa, MD, PhD1, Courtney Crane1, Seunggu J. Han, MD1, Valerie Kivett1, Anne Fedoroff RN1, Nicholas Butowski, MD1, Susan Chang, MD1, Michael Prados, MD1, Jennifer Clarke1, Mitchel S. Berger, MD1, Michael W. McDermott, MD1, Manish K. Aghi, MD1


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     HSPPC-96 is made from a patient’s individual tumor containing glycoprotein-96 associated with cancer-specific antigenic peptides, and has been successfully tested in a Phase I clinical trial for recurrent GBM patients.
     There is a need for new adjuvant therapies for the treatment of recurrent GBM patients undergoing surgical resection.
     43 patients with a median KPS of 80 and median age of 53 years were entered.
     This Phase 2 multicenter clinical trial was designed to evaluate overall survival post-operatively after vaccination with HSPPC-96. Eligibility criteria included: 1) diagnosis of recurrent GBM,2) KPS<70, and 3) radiographic confirmation of <90% resection.
     The vaccine was well tolerated with no related grade 3 or 4 toxicities. As of August 2011, the median survival for evaluable patients was 47.6 weeks (25%-75% percentiles=37.1-60.7) and 6-month survival was 93%. 86 consecutive patients not enrolled on the HSPPC-96 clinical trial, but treated during the study period who underwent <90% resection of recurrent GBM with KPS<70 had a median overall survival of only 32.8 weeks and a 6-month survival of 68%. HSPCC-96 treated patients lived significantly longer (p<0.01).
     This was a prospective, non-randomized study.
     Survival data available to date indicates HSPPC-96 vaccine provides a possible clinical benet for recurrent GBM patients. HSPPC-96 results are superior to similar surgical populations identified in the literature as well as a contemporary cohort controlled for age, KPS, and extent of resection.
     These results provide the impetus for further testing against currently approved therapies for patients with recurrent GBM.


Project Roles:

A. Parsa (), C. Crane (), S. Han (), V. Kivett (), A. RN (), N. Butowski (), S. Chang (), M. Prados (), J. Clarke (), M. Berger (), M. McDermott (), M. Aghi ()