Clinical trial · Interventional
Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine
A Phase I and Feasibility Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Pediatric Patients With Newly Diagnosed Intracranial High Grade Glioma and Recurrent Resectable Intracranial High Grade Glioma and Ependymoma
NCT02722512CI-TRIAL-00086160terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of substantial evidence for immune responses in response to vaccination.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and Ependymomas.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Ependymoma | Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Astrocytoma, Grade III | Anaplastic Astrocytoma | ALIAS | 0.90 |
| Clear Cell Ependymoma | Clear Cell Ependymoma | ONTOLOGY_EXACT | 0.98 |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Heat Shock Protein Peptide Complex-96 (HSPPC-96) | Biological | — | UNRESOLVED |
| Radiation | Radiation | — | UNRESOLVED |
| Tumor Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Newly Diagnosed High Grade Glioma (HGG)
- description
- 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.
- interventionNames
- Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96)
- Procedure: Tumor Resection
- Radiation: Radiation
- type
- EXPERIMENTAL
- label
- Recurrent HGG and Ependymoma
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.