Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine
Glioblastoma Multiforme, Astrocytoma, Grade III, Anaplastic Ependymoma
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme
Eligibility Criteria
Inclusion Criteria:
- Arm A: Newly Diagnosed High Grade Glioma Tumor
- Arm B: Recurrent, resectable High Grade Glioma or Ependymoma
- Stable Neurologic Status
- Lanksy/Karnofsky score greater than or equal to 50.
- Adequate Bone Marrow Function (ANC≥ 1000/μL, platelets≥ 100,000/μL transfusion independent, Hemoglobin ≥ 8.0 gm/dL with or without transfusion support)
- Adequate Liver Function (Bilirubin ≤ 2x institutional normal for age, Alanine transaminase (ALT) ≤ 5x institutional normal for age, Aspartate Aminotransferase (AST) ≤ 5x institutional normal for age)
- Adequate Renal Function (Normal creatinine for age and/or glomerular filtration rate ≥ 70 mls/min/1.73 m2)
- Female patients of childbearing potential must have a negative serum or urine pregnancy test
Exclusion Criteria:
- Patients with unresectable disease are not eligible.
- Patients with primary spinal cord tumors are not eligible.
- Patients with metastatic disease are not eligible for Arm A (this does NOT apply to Arm B).
- Patients with a known allergy to any component of the vaccine or any compounds of similar chemical or biologic composition of the vaccine are not eligible.
- Patients with known auto-immune disease are excluded.
- Patients with known immunodeficiency are excluded.
- Patients with a concurrent malignancy are excluded.
- Clinically Significant Concurrent Illness
- Patients receiving any other anticancer or investigational drug
- Patients with uncontrolled seizure disorders
- Patients whose central nervous system (CNS) tumor is considered a secondary malignancy from prior therapies
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Newly Diagnosed High Grade Glioma (HGG)
Recurrent HGG and Ependymoma
Heat Shock Protein Peptide Complex-96 (HSPPC-96) therapy will be given between 0-28 days after the completion of radiation therapy (XRT) AND no more than 60 days from completion of XRT. Vaccine will be given once weekly for 4 weeks. The 4 weeks (28 days) of vaccine administration will be followed by an observation visit. In patients with sufficient vaccine (on both Arms A and B), a maintenance therapy will be instituted. It will be administered at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be administered 7 days after completion of the observation visit.
On Arm B, Heat Shock Protein Peptide Complex-96 (HSPPC-96) will be given as soon as possible after tumor resection post-operative recovery and sufficient time for vaccine preparation (typically 0-28 days post-operatively) AND no more than 60 days post-operatively. Vaccine will be given once weekly for 4 weeks. These 4 weeks (28 days) of vaccines will be followed by an observation visit. In patients with sufficient vaccine, a maintenance therapy will be given. It will be given at the same dose the patient was enrolled at and given every 2 weeks until vaccine is exhausted or there is evidence of tumor progression. The first dose of maintenance vaccine should be given 7 days after completion of the observation visit.