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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Glioblastoma Multiforme; Astrocytoma, Grade III; Anaplastic Ependymoma; Clear Cell Ependymoma; Ependymoma	Biological: Heat Shock Protein Peptide Complex-96 (HSPPC-96); Procedure: Tumor Resection; Radiation: Radiation	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2016
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	May 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Newly Diagnosed High Grade Glioma (HGG); 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); 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. Procedure: Tumor Resection; Clinically-indicated removal of the tumor Radiation: Radiation; Focal Radiation Therapy
Experimental: Recurrent HGG and Ependymoma; 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); 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. Procedure: Tumor Resection; Clinically-indicated removal of the tumor

Outcome Measures

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Primary Outcome Measures :

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. [ Time Frame: 36 months ]

Secondary Outcome Measures :

1. To estimate the progression-free survival distribution in children with recurrent and resectable HGG treated with HSPPC-96 vaccine therapy alone (Arm B). [ Time Frame: 60 months ]
2. To estimate the progression-free survival distribution in children with recurrent and resectable ependymoma treated with HSPPC-96 vaccine therapy alone (Arm B). [ Time Frame: 60 months ]
3. To evaluate patient immune responses as measured by immune correlates in the above patient groups. [ Time Frame: 60 months ]

Eligibility Criteria

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Ages Eligible for Study:	3 Years to 21 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Contacts

Contact: Jason Fangusaro, MD	312-227-4090	jfangusaro@luriechildrens.org

Locations

United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago	Recruiting
Chicago, Illinois, United States, 60611
Contact: Emily Golbeck, BS, CCRP 312-227-4858 egolbeck@luriechildrens.org
Sub-Investigator: Stewart Goldman, MD
Sub-Investigator: Rishi Lulla, MS, MD
Sub-Investigator: Natasha Pillay-Smiley, DO

Sponsors and Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

Principal Investigator:	Jason Fangusaro, MD	Ann and Robert H. Lurie Childrens Hospital of Chicago

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:	NCT02722512 History of Changes
Other Study ID Numbers:	2016-362
First Posted:	March 30, 2016
Last Update Posted:	July 21, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Ependymoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Vaccines; Immunologic Factors; Physiological Effects of Drugs