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Vaccine Trial for Low-Grade Gliomas in Children and Young Adults

This study is testing a vaccine called HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC in children and young adults (ages 12 months to 21 years) who have low-grade gliomas (a type of brain tumor) that cannot be removed by surgery. To join, your tumor must have already been treated with at least two chemotherapy or biologic treatments, and you must be HLA-A2 positive (a specific genetic marker). The vaccine is given as injections, along with Poly-ICLC, which helps the vaccine work. Researchers will look for tumor shrinkage or stable disease (meaning the tumor doesn't grow) at 24 weeks to see if the treatment is successful. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 25 participants. It is testing a specific vaccine and Poly-ICLC treatment.
What's involved
You would receive subcutaneous injections of the vaccine and intramuscular injections of Poly-ICLC every 3 weeks for up to 8 cycles. You would also have clinical visits and MRI scans at Weeks 6, 15, and 24.
Compensation
Not stated in the trial record.
Follow-up
Follow-up MRI scans are performed at Weeks 6, 15, and 24 to assess responses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02358187

A Vaccine Trial for Low Grade Gliomas

Recruiting
PHASE2Ages 12–21InterventionalTreatment
James Felker
~25 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor shrinkage or stable disease
Measured over Week 24

Conditions

Low Grade Glioma

Explore related trials

Low Grade GliomaHLA Class I Histocompatibility Antigen, A-2 Alpha Chain

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • James Felker, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

James Felker, MD
412 692-5055
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Patients with adequate organ function as measured by: Bone marrow: absolute neutrophil count (ANC) \> 1,000/µ; Platelets \> 100,000/µ (transfusion independent); absolute lymphocyte count of ≥ 500/µ; Hemoglobin \>8 g/dl (may be transfused). Hepatic: bilirubin \< 1.5x institutional normal for age; serum glutamate pyruvate transaminase (SGPT) \< 3x institutional normal.
Renal: Serum creatinine based on age or Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml/min/ml/min/1.73 m²
Patients must have recovered from the toxic effects of prior therapy to grade 1 or better. Patients must be at least 3 weeks from the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.
No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

Exclusion

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
Patients must not have a history of, or currently active autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement.
Use of immunosuppressives within four weeks prior to study entry or anticipated use of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period must be tapered to no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone for at least one week before study registration. Topical corticosteroids are acceptable.
Because patients with immune deficiency are not expected to respond to this therapy, HIV-positive patients are excluded from the study.
Patients who have received prior immunotherapy.

What this trial measures

  • Tumor shrinkage or stable diseaseWeek 24

    Participants who demonstrate radiological evidence of tumor shrinkage or stable disease without regimen-limiting toxicity (RLT) after the initial 8 vaccines will be eligible to receive additional vaccinations beginning week 24 and every 6 weeks thereafter for up to two years.