RecruitingLow Grade Glioma
A Vaccine Trial for Low Grade Gliomas
Eligible age
1–21 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The study will assess the immunogenicity, safety and preliminary clinical efficacy of the glioma associated antigen (GAA)/tetanus toxoid (TT) peptide vaccine and poly-ICLC in HLA-A2+ children with unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as one biologic regimen, but patients may not have received radiation to the index lesion within 1 year of enrollment.
Sponsor: James Felker
You may qualify if…
- ✓ Tumor Type
- ✓ Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not have received radiation therapy to the index lesion within 1 year of enrollment. Patients may have tumor spread within the central nervous system (CNS).
- ✓ HLA-A2 positive based on flow cytometry.
- ✓ Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
- ✓ Patients must be ≥ 12 months and \< 22 years of age at the time of HLA-A2 screening.
- ✓ Patients must have a performance status of ≥ 70; (Karnofsky if \> 16 years and Lansky if ≤ 16 years of age.
- ✓ Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal. Because the effect of the peptide-based vaccine and poly-ICLC on the fetus has not sufficiently been investigated, pregnant females will not be included in the study.
- ✓ Patients must be free of systemic infection requiring IV antibiotics at the time of registration. Patients must be off IV antibiotics for at least 7 days prior to registration.
You may not qualify if…
- ✕ Patients living outside of North America are not eligible.
- ✕ Patients may not have received radiation to the index lesion within 1 year of enrollment.
- ✕ Concurrent treatment or medications (must be off for at least 1 week) including:
- ✕ Interferon (e.g. Intron-A®)
- ✕ Allergy desensitization injections
- ✕ Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
- ✕ Interleukins (e.g. Proleukin®)
- ✕ Any investigational therapeutic medication
Where it's recruiting
Pennsylvania
Pittsburgh
Source: ClinicalTrials.gov · NCT02358187 · last updated 2026-01-07