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 range
3 Years – 21 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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