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Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma

NCT02549833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-11-22

No results posted yet for this study

Summary

This is a pilot neoadjuvant vaccine study in adults with WHO grade II glioma, for which surgical resection of the tumor is clinically indicated. Co-primary objectives are to determine: 1) the safety and feasibility of the neoadjuvant approach; and 2) whether the regimen increases the level of type-1 chemokine CXCL10 and vaccine-specific (i.e., reactive to GBM6-AD) CD8+ T-cells in tumor-infiltrating leukocytes (TILs) in the surgically resected glioma.

Conditions

  • Oligodendroglioma
  • Astrocytoma, Grade II
  • Glioma, Astrocytic
  • Glioma
  • Malignant Glioma
  • Oligoastrocytoma, Mixed

Interventions

BIOLOGICAL

GBM6-AD and poly-ICLC before and after surgery

Subcutaneous vaccination with GBM6-AD lysate protein and poly-ICLC combination

BIOLOGICAL

GBM6-AD and poly-ICLC after surgery only

Subcutaneous vaccination with GBM6-AD lysate protein and poly-ICLC combination

Sponsors & Collaborators

Principal Investigators

  • Jennie Taylor, MD · University of California, San Francisco

  • Hideho Okada, MD, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-17
Primary Completion
2022-08-15
Completion
2024-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02549833 on ClinicalTrials.gov