A Vaccine Trial for Low Grade Gliomas

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
James Felker
Study ID
NCT02358187
Phase
PHASE2
Status
Recruiting
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Conditions

  • Low Grade Glioma

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2015
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
    All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.

Primary Outcome Measure

Tumor shrinkage or stable disease [ Time Frame: Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224
Sharon Dibridge
[email protected]
412-692-7070

Find similar trials in Pittsburgh, PA

By research site
Children's Hospital of Pittsburgh of UPMC· Pittsburgh, PA

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