Glioblastoma Multiforme Clinical Trial
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
Verified date | July 2020 |
Source | Ann & Robert H Lurie Children's Hospital of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | November 13, 2019 |
Est. primary completion date | November 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 21 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago | Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | To evaluate patient immune responses as measured by immune correlates in the above patient groups. | 60 months |
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