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.