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

Inclusion Criteria

• •1. Age \> or equal to 18 years old
• •2. Life expectancy of greater than 12 weeks.
• •3. Able to read and understand the informed consent document; must sign the informed consent
• •4. Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease
• •5. Must be eligible for post-surgical treatment with radiotherapy and temozolomide
• •1. Agree to use contraception or abstain from sexual activity from the time of consent through 1 month after the end of study drug administration
• •2. Negative serum pregnancy test for female patients of childbearing potential
• •3. Patients with histologically proven, non-progressive glioblastoma multiforme (GBM)
• •4. Patient must have received standard of care radiation and temozolomide therapy
• •5. Must have undergone a at least a 90% resection (determined by the principal investigator (PI)) measured by postoperative magnetic resonance imaging (MRI) scan, T1-weighted contrast scan, or CT scan if clinically indicated, performed within 72 hours after surgery
• •6. All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior to the first planned vaccine administration
• •7. Availability of at least 4 doses of vaccine (at least 4 vials for clinical administration produced from the tumor provided)
• •8. Karnofsky functional status rating \> or equal to 70
• •9. Adequate bone marrow function including the absence of lymphopenia (ANC \> 1,500/ mm3; absolute lymphocyte count (ALC) \> 500/mm3 ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase (AST), alanine amino transferase (ALT), and alkaline phosphatase \<2.5 times institutional upper limit of normals \[IULNs\] and bilirubin (total) \<1.5 mg\*IULN), and adequate renal function (BUN and creatinine \<1.5 times IULNs