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
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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