Actively Recruiting
A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas
Led by James Felker · Updated on 2026-01-07
25
Participants Needed
1
Research Sites
104 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
This research aims to evaluate the immune response, safety, and early signs of effectiveness of a vaccine combining glioma-associated antigen (GAA)/tetanus toxoid (TT) peptides with poly-ICLC in children and young adults aged 12 months to under 22 years who have unresectable low-grade gliomas. Participants must have previously undergone at least two chemotherapy or biological treatments, including radiation therapy if applied more than one year prior to enrollment. The study focuses on those who are HLA-A2 positive and clinically stable. Participants will receive subcutaneous injections of the GAA/TT vaccine starting at Week 0, repeated every three weeks for up to eight doses or until treatment must be stopped. Following each vaccine dose, an intramuscular injection of poly-ICLC will be administered near the vaccine injection site. Doses may be given within one week of the scheduled date to accommodate scheduling flexibility. The intervention group includes all participants receiving these combined treatments. Throughout the study, participants will have clinical visits and MRI scans to monitor tumor response and any adverse effects. MRIs will be performed at Weeks 6, 15, and 24 to assess tumor shrinkage or stability. Participants will be observed for possible side effects, including regimen limiting toxicity, and asked to report any temperature changes after treatment. The primary outcome measure is tumor shrinkage or stable disease at Week 24, with safety and immunogenicity also assessed during follow-up.
CONDITIONS
Brief Title
A Vaccine Trial for Low Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unresectable low-grade gliomas that have received at least two chemotherapy or biologic regimens, including radiation therapy if given more than one year before enrollment
- HLA-A2 positive based on flow cytometry
- Clinically stable and off or on low-dose corticosteroids (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) for at least one week prior to registration
- Aged 12 months to under 22 years at time of HLA-A2 screening
- Performance status of 70 or higher (Karnofsky if older than 16 years, Lansky if 16 years or younger)
- Female patients who are post-menarchal must have a negative serum beta-human chorionic gonadotropin (HCG) test
- Free of systemic infection requiring intravenous antibiotics and off IV antibiotics for at least 7 days prior to registration
- Adequate organ function including bone marrow, liver, and kidney function as defined by study parameters
- Recovered from prior therapy toxic effects to grade 1 or better
- At least 3 weeks from last standard cytotoxic chemotherapy or myelosuppressive biologic therapy, and at least 1 week from last non-myelosuppressive biologic therapy
- No overt cardiac, gastrointestinal, pulmonary, or psychiatric disease
You will not qualify if you...
- Living outside of North America
- Radiation therapy to the index lesion within 1 year of enrollment
- Concurrent treatment or medications including interferon, allergy desensitization injections, growth factors, interleukins, or any investigational therapeutic medication (must be off for at least 1 week)
- History of or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement
- Use of immunosuppressive agents within 4 weeks prior to study entry or anticipated use
- HIV-positive status
- Previous immunotherapy treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive subcutaneous injections of glioma antigen peptides combined with intramuscular Poly-ICLC every 3 weeks for up to 8 cycles or until off-treatment criteria are met.
Up to 8 visits every 3 weeks (in-person)
Duration - Up to 24 weeks
Participants are monitored with clinical visits and MRI scans at Weeks 6, 15, and 24 to evaluate adverse events and clinical responses.
3 visits for MRI scans and clinical evaluation
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
S
Sharon Dibridge
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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