Trials / Recruiting
RecruitingNCT06914479
Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors
A Phase 1 Study of a Combined Cytotoxic and Immune-Stimulatory Therapy in Pediatric and Young Adult Patients With Recurrent, Primary Malignant Brain Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (estimated)
- Sponsor
- University of Michigan Rogel Cancer Center · Academic / Other
- Sex
- All
- Age
- 3 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial tests the safety, side effects and best dose of AdV-HSV1-TK and AdV-Flt3L in combination with valacyclovir for the treatment of patients with primary cancerous (malignant) brain tumors that can be removed by surgery (resectable) and that have come back after a period of improvement (recurrent). AdV-HSV1-TK and AdV-Flt3L use a virus modified in the laboratory to kill tumor cells and stimulate the immune system to recognize the tumor cells as "invaders" which can lead to tumor shrinkage. For this process to work, an oral anti-herpes medication called valacyclovir is also needed. Giving AdV-HSV1-TK, AdV-Flt3L and valacyclovir may be safe, tolerable and/or effective in treating patients with resectable, recurrent primary malignant brain tumors.
Conditions
- Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant
- Recurrent Malignant Brain Neoplasm
- Resectable Brain Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Ad-hCMV-Flt3L | Given via injection |
| GENETIC | Ad-hCMV-TK | Given via injection |
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| PROCEDURE | Magnetic Resonance Imaging | Undergo MRI |
| OTHER | Survey Administration | Ancillary studies |
| PROCEDURE | Tumor Resection | Undergo standard of care tumor resection |
| DRUG | Valacyclovir | Given PO |
Timeline
- Start date
- 2026-06-01
- Primary completion
- 2031-06-01
- Completion
- 2031-06-01
- First posted
- 2025-04-06
- Last updated
- 2026-03-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06914479. Inclusion in this directory is not an endorsement.