Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
NCT05686798 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-12-16
Summary
The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.
Conditions
- Malignant Glioma of Brain
- Astrocytoma
- Malignant Astrocytoma
- Brain Tumor
- Glioma
- Brain Cancer
- Glioblastoma
- Glioblastoma Multiforme
- GBM
Interventions
- BIOLOGICAL
-
Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS)
Ad5-yCD/mutTKSR39rep-ADP adenovirus will be injected intratumoral
Sponsors & Collaborators
-
Henry Ford Health System
lead OTHER
Principal Investigators
-
Tobias Walbert, MD, PhD · Henry Ford Health System
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-29
- Primary Completion
- 2027-01-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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