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HLA-A2-Restricted Glioma Antigen-Peptides Vaccinations With Poly-ICLC for Recurrent WHO Grade II Gliomas

NCT00874861 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-08

No results posted yet for this study

Summary

This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of this study is to test the safety and efficacy of an experimental tumor vaccine made from peptides in combination with the study drug Poly-ICLC.

Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.

The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted.

Conditions

Interventions

BIOLOGICAL

Peptide vaccine + Poly-ICLC

Subcutaneously in right or left upper arms with intact draining axillary nodes. Each will be injected to the same location in the same arm as the previous vaccine was administered. In case of no intact axillary lymph nodes as draining nodes, vaccines will be administered in the upper thigh on the same side with intact inguinal lymph nodes. Vaccine will be administered on weeks 0,3,6,9,12,15,18 and 21. Poly-ICLC First course(20 mg/kg i.m., up to 1640 µg/injection) will be administered on an outpatient basis in the Clinical \& Translational Research Center (CTRC)the day of the first GAA/TT-vaccine and on day 4 after the vaccine. For each of the repeated vaccinations (on Weeks 3,6,9,12,15,18 and 21) poly-ICLC will be administered on day of the vaccine and on day 4 after the vaccine.

Sponsors & Collaborators

  • Musella Foundation

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ian F. Pollack, M.D.

    lead OTHER

Principal Investigators

  • Frank Lieberman, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-05-31
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874861 on ClinicalTrials.gov