Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine (NCT02722512) | Clinical Trial Compass
TerminatedPhase 1
Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine
Stopped: Lack of substantial evidence for immune responses in response to vaccination.
United States10 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range3 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
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.
Timeframe: 36 months
Trial details
NCT IDNCT02722512
SponsorAnn & Robert H Lurie Children's Hospital of Chicago