OncoMatch/Clinical Trials/NCT06914479
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
Is NCT06914479 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Valacyclovir for recurrent diffuse hemispheric glioma, h3 g34-mutant.
Treatment: Valacyclovir — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: HIST1H3B G34 mutation
Diagnosis of diffuse hemispheric glioma, H3 G34-mutant, per 2021 World Health Organization (WHO) classification
Prior therapy
Must have received: standard-of-care therapy — up-front
who have completed up-front, standard-of-care therapy
Cannot have received: gene therapy
History of prior gene therapy
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3 (1.0g/l); Platelet count ≥ 100,000/mm^3 (100x10^9/l) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m^2 or a serum creatinine within the normal limits for age
Liver function
Bilirubin (sum of conjugated + unconjugated) ≤ 2 x upper limit of normal (ULN) for age; Alanine aminotransferase (ALT) ≤ 3 x ULN; Serum albumin ≤ 2 g/dL
Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3 (1.0g/l); Platelet count ≥ 100,000/mm^3 (100x10^9/l) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment); Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m^2 or a serum creatinine within the normal limits for age; Bilirubin (sum of conjugated + unconjugated) ≤ 2 x upper limit of normal (ULN) for age; Alanine aminotransferase (ALT) ≤ 3 x ULN; Serum albumin ≤ 2 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
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