Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma

NCT02062827 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-10-02

Study results available
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Summary

To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma

Conditions

  • Recurrent Glioblastoma Multiforme
  • Progressive Glioblastoma Multiforme
  • Anaplastic Astrocytoma or Gliosarcoma

Interventions

BIOLOGICAL

M032 (NSC 733972)

A single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • James M. Markert, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-25
Primary Completion
2022-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02062827 on ClinicalTrials.gov