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Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.

Glioblastoma Clinical Trial

Official title:
Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas

Clinical Trial 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.

Clinical Trial Description

Detailed study description: Patients with recurrent glioblastoma (GBM) or progressive high grade astrocytoma who are scheduled to undergo repeat surgery are eligible. After the removal of as much tumor tissue as possible, a modified oncolytic adenovirus is injected into the wall of the resection cavity and any residual tumor tissue. The goal of this study is to determine the maximum tolerated dose (MTD) of the injected adenovirus. This treatment is combined with a combination of oral 5-fluorocytosine (5-FC) and valganciclovir (vGCV) prodrug therapy. Following the surgery, patients will be treated with fractionated radiosurgery (fSRS). Patients will be monitored for 30 days before they start on next line anti-cancer therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05686798
Study type Interventional
Source Henry Ford Health System
Contact Tobias Walbert, MD, PhD
Phone 3139162723
Email twalber1@hfhs.org
Status Recruiting
Phase Phase 1
Start date November 29, 2022
Completion date October 2024
View Details
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