A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas

Phase 1

Completed

• Conditions: Newly Diagnosed Pediatric Pontine Glioma; Newly Diagnosed Pediatric High Grade Glioma; Recurrent Pediatric Low Grade Glioma; Recurrent Pediatric High Grade Glioma
• Interventions: Biological: HLA-A2 restricted glioma antigen peptides vaccine; Biological: Poly-ICLC

• Registration Number: NCT01130077
• Lead Sponsor: James Felker

Brief Summary

The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Status Verified: 2023-10
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Patients living outside of North America are not eligible.

Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.

Patients in Stratum F must have tumor spread within the CNS.

Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.

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.

Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (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.

Patients with known addiction to alcohol or illicit drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLA Restricted glioma antigen peptides plus Poly ICLC	HLA-A2 restricted glioma antigen peptides vaccine	All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
HLA Restricted glioma antigen peptides plus Poly ICLC	Poly-ICLC	All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

Primary Outcome Measures

Name	Time	Method
Safety: Tolerability during the first two vaccine courses as defined in the protocol.	6 weeks	Tolerability during the first two vaccine courses as defined in the protocol.

Secondary Outcome Measures

Name	Time	Method
Glioma-associated antigen-specific T-cell response	Monitoring will continue as long as subject remains on study.	Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States