A Vaccine Trial for Low Grade Gliomas

ConditionLow Grade Glioma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age12-21

SponsorJames Felker

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients living outside of North America are not eligible.

Patients may not have received radiation to the index lesion within 1 year of enrollment.

Interferon (e.g. Intron-A®)

Allergy desensitization injections

Trial design

Design model

Single group

Treatments tested in this trial

Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
Biological/Vaccine
Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Tumor shrinkage or stable disease

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.

Time frame

Week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

James Felker

Lead sponsor

University of Pittsburgh

Sponsor institution

Connor's Cure

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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