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

NCT02722512 Phase 1 TERMINATED

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.

Details

Lead sponsor	Ann & Robert H Lurie Children's Hospital of Chicago
Phase	Phase 1
Status	TERMINATED
Enrolment	10
Start date	2016-07
Completion	2019-11-13

Conditions

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

Interventions

• Heat Shock Protein Peptide Complex-96 (HSPPC-96)
• Tumor Resection
• Radiation

Primary outcomes

• 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

Countries

United States