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

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.

NCT Number	NCT06914479
Lead Sponsor	University of Michigan Rogel Cancer Center
Conditions	Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant, Recurrent Malignant Brain Neoplasm, Resectable Brain Neoplasm
Enrollment	11 participants
Start Date	2026-05-22
Primary Completion	2031-05 (estimated)
Study Completion	2031-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-15