Clinical Trial Details
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NCT02722512 : Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine
PhasePhase 1
AgesMin: 3 Years Max: 21 Years
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
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