RecruitingPhase 1NCT06914479

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


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

11 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a virus-based gene therapy combination — two engineered viruses that infect and kill cancer cells, given with an antiviral drug — delivered directly into the brain tumor during surgery, for children and young adults with recurring malignant brain tumors. **You may be eligible if...** - You are between 3 and 25 years old with a malignant brain tumor that has come back or progressed after standard treatment — OR — you are 26–39 years old with a specific brain tumor type (diffuse hemispheric glioma, H3 G34-mutant) that has relapsed - You weigh at least 10 kg - Surgery to remove the recurring tumor is planned - You have recovered from side effects of prior treatments **You may NOT be eligible if...** - You have not completed standard-of-care therapy before this trial - You have not waited the required time since your last chemotherapy, radiation, or immunotherapy - Your parent/guardian (or you, if an adult) is not able to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICAd-hCMV-Flt3L

Given via injection

GENETICAd-hCMV-TK

Given via injection

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERSurvey Administration

Ancillary studies

PROCEDURETumor Resection

Undergo standard of care tumor resection

DRUGValacyclovir

Given PO


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06914479


Related Trials