Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine

NCT02722512 | Terminated Phase 1 DMC

• 1 other identifier: 2016-362
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Glioblastoma Multiforme; Astrocytoma, Grade III; Anaplastic Ependymoma; Clear Cell Ependymoma; Ependymoma

Outcome Measures

Primary Outcomes (1)

• The rolling 6 statistical design will be utilized to establish the MTD and RP2D of HSPCC autologous vaccine in children with newly diagnosed high grade glioma (HGG) following focal radiation therapy and in recurrent HGG and ependymoma given alone.

  36 months

Secondary Outcomes (3)

• To estimate the progression-free survival distribution in children with recurrent and resectable HGG treated with HSPPC-96 vaccine therapy alone (Arm B).

  60 months

• To estimate the progression-free survival distribution in children with recurrent and resectable ependymoma treated with HSPPC-96 vaccine therapy alone (Arm B).

  60 months

• To evaluate patient immune responses as measured by immune correlates in the above patient groups.

  60 months

Study Arms (2)

Newly Diagnosed High Grade Glioma (HGG)

EXPERIMENTAL

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.

Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96); Procedure: Tumor Resection; Radiation: Radiation

Recurrent HGG and Ependymoma

EXPERIMENTAL

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.

Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96); Procedure: Tumor Resection

Interventions

Heat Shock Protein Peptide Complex-96 (HSPPC-96) BIOLOGICAL

The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis.

Newly Diagnosed High Grade Glioma (HGG); Recurrent HGG and Ependymoma

Tumor Resection PROCEDURE

Clinically-indicated removal of the tumor

Newly Diagnosed High Grade Glioma (HGG); Recurrent HGG and Ependymoma

Radiation RADIATION

Focal Radiation Therapy

Newly Diagnosed High Grade Glioma (HGG)

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University: collaborator

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Ependymoma

Interventions

vitespin; Transurethral Resection of Bladder; Radiation

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Physical Phenomena

Study Officials

• Stewart Goldman, MD

  Ann and Robert H Lurie Childrens Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Head, Pediatric NeuroOncology

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 30, 2016
• Study Start: July 1, 2016
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

US (1)