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Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent Grade II Gliomas

NCT01678352 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-02-24

No results posted yet for this study

Summary

This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with WHO grade II glioma. The proposed regime with BTIC Lysate in combination with imiquimod, an FDA-approved immune response modifier will induce potent anti-glioma immune response with minimal or no toxicity.

Conditions

  • High Risk WHO Grade II Glioma
  • Recurrent/Post-Chemotherapy WHO Grade II Glioma

Interventions

BIOLOGICAL

Tumor Lysate Vaccine

Cohort 1 Cohort 2 Cohort 3

DRUG

Imiquimod

Cohort 1 Cohort 2 Cohort 3

Sponsors & Collaborators

Principal Investigators

  • Frank Lieberman, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-11-08
Completion
2018-11-08

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01678352 on ClinicalTrials.gov