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
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age 3 to 25 years with: * Diagnosis of malignant primary brain tumor after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy * Age 26 to 39 years with: * Diagnosis of diffuse hemispheric glioma, H3 G34-mutant, per 2021 World Health Organization (WHO) classification, after tumor recurrence, relapse, or progression who have completed up-front, standard-of-care therapy * At least 10 kg (and body surface area \[BSA\] \> 0.5 m\^2) * Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 3 days prior to baseline MRI * Surgical resection of the tumor recurrence/relapse/progression is clinically indicated at the time of enrollment * A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate * Participant must be willing to provide archival formalin-fixed embedded (FFPE) and/or frozen tissue specim