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Clinical Trials/NCT01130077
NCT01130077
Completed
Phase 1

A Pilot Study to Evaluate the Effects of Vaccinations with HLA-A2-Restricted Glioma Antigen-Peptides with Poly-ICLC for Children with Newly Diagnosed Malignant Brain Stem Gliomas, Non-Brainstem High-Grade Gliomas, Recurrent Low-Grade Gliomas or Recurrent High Grade Gliomas

James Felker1 site in 1 country60 target enrollmentFebruary 2009
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ConditionsNewly Diagnosed Pediatric Pontine GliomaNewly Diagnosed Pediatric High Grade GliomaRecurrent Pediatric High Grade GliomaRecurrent Pediatric Low Grade Glioma
InterventionsHLA-A2 restricted glioma antigen peptides vaccinePoly-ICLC
DrugsHLA-A2 restricted glioma antigen peptides vaccinePoly-ICLC

Overview

Phase
Phase 1
Intervention
HLA-A2 restricted glioma antigen peptides vaccine
Conditions
Newly Diagnosed Pediatric Pontine Glioma
Sponsor
James Felker
Enrollment
60
Locations
1
Primary Endpoint
Safety: Tolerability during the first two vaccine courses as defined in the protocol.
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

James Felker

Assistant Professor

University of Pittsburgh

Eligibility Criteria

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

Arms & Interventions

HLA Restricted glioma antigen peptides plus Poly ICLC

All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

Intervention: HLA-A2 restricted glioma antigen peptides vaccine

HLA Restricted glioma antigen peptides plus Poly ICLC

All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

Intervention: Poly-ICLC

Outcomes

Primary Outcomes

Safety: Tolerability during the first two vaccine courses as defined in the protocol.

Time Frame: 6 weeks

Tolerability during the first two vaccine courses as defined in the protocol.

Secondary Outcomes

  • Glioma-associated antigen-specific T-cell response(Monitoring will continue as long as subject remains on study.)

Study Sites (1)

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