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Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas

NCT00795457 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-08-30

No results posted yet for this study

Summary

This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC.

Poly-ICLC, manufactured by Oncovir, Inc., has already been received and 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 in each of two patient cohorts.

Conditions

Interventions

BIOLOGICAL

GAA/TT-peptide vaccine and poly-ICLC

Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.

BIOLOGICAL

GAA/TT-peptide vaccine and poly-ICLC

Participants will be treated with subcutaneous injections of GAA/TT-vaccines on Weeks 0, 3, 6, 9, 12, 15, 18 and 21. I.m. poly-ICLC will be administered (20 mg/kg i.m.) on the day of, and on day 4 after each vaccine (e.g. if the vaccine is administered on Thursday, poly-ICLC will be administered on the day of vaccine and the following Monday). Each vaccine will be administered within 2 hours before or after the i.m. poly-ICLC administration.

Sponsors & Collaborators

  • Oncovir, Inc.

    collaborator INDUSTRY

  • 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-02-28
Completion
2015-07-31

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 NCT00795457 on ClinicalTrials.gov