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

Status: Terminated

Location: See location...

Intervention Type: Radiation, Biological, Procedure

Study Type: Interventional

Study Phase: Phase 1

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 3

Maximum Age: 21

Healthy Volunteers: f

View:

• 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

Locations

United States

Illinois

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

Chicago

Time Frame

Start Date: 2016-07

Completion Date: 2019-11-13

Participants

Target number of participants: 10

Treatments

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.

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.

Authors

Natasha Pillay-Smiley, Rishi Lulla, Jason Fangusaro, Stewart Goldman

Related Therapeutic Areas

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

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