Trials / Recruiting
RecruitingNCT05686798
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Malignant Glioma of Brain
- Astrocytoma
- Malignant Astrocytoma
- Brain Tumor
- Glioma
- Brain Cancer
- Glioblastoma
- Glioblastoma Multiforme
- GBM
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS) | Ad5-yCD/mutTKSR39rep-ADP adenovirus will be injected intratumoral |
Timeline
- Start date
- 2022-11-29
- Primary completion
- 2027-01-01
- Completion
- 2027-12-01
- First posted
- 2023-01-17
- Last updated
- 2025-12-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05686798. Inclusion in this directory is not an endorsement.