Actively Recruiting
A Vaccine Trial for Low Grade Gliomas
Led by James Felker · Updated on 2026-01-07
25
Participants Needed
1
Research Sites
730 weeks
Total Duration
On this page
Sponsors
J
James Felker
Lead Sponsor
C
Connor's Cure
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Vaccine Trial for Low Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unresectable low-grade gliomas with at least two prior chemotherapy or biologic regimens; radiation counts as one regimen
- No radiation therapy to the tumor site within 1 year before enrollment
- HLA-A2 positive based on flow cytometry
- Clinically stable and on low-dose corticosteroids (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) or off corticosteroids for at least 1 week before enrollment
- Age 12 months to less than 22 years at HLA-A2 screening
- Performance status of 70 or higher (Karnofsky if over 16 years, Lansky if 16 years or younger)
- Negative serum beta-human chorionic gonadotropin (HCG) for post-menarchal female patients
- No systemic infection requiring IV antibiotics; off IV antibiotics for at least 7 days before enrollment
- Adequate organ function including bone marrow, liver, and kidney function
- Recovered from toxic effects of prior therapy to Grade 1 or better
- At least 3 weeks since last standard cytotoxic chemotherapy or myelosuppressive biologic therapy
- At least 1 week since last non-myelosuppressive biologic therapy
- No overt cardiac, gastrointestinal, pulmonary, or psychiatric disease
You will not qualify if you...
- Living outside North America
- Radiation to tumor site within 1 year prior to enrollment
- Concurrent treatments including interferon, allergy desensitization injections, growth factors, interleukins, or investigational medications; these must be stopped at least 1 week before enrollment
- History or active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or with visceral involvement
- Use of immunosuppressive agents within 4 weeks prior to study entry or planned use during study; corticosteroids must be tapered to low doses before enrollment
- HIV positive status
- Prior immunotherapy treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
Research Team
J
James Felker, MD
CONTACT
S
Sharon Dibridge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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