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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06914479•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

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

Age

3 - 39 years

Sex

ALL

Healthy Volunteers

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 specimens, if available
•Participant must have recovered from all acute side effects of prior therapy.
+18 more criteria

Exclusion Criteria

•Patient deemed not clinically appropriate to undergo tumor tissue resection by a neurosurgeon
•Evidence of disseminated disease, including diffuse leptomeningeal disease or evidence of cerebrospinal fluid (CSF) dissemination
•Patient with primary brainstem or primary spinal tumors
•History of prior gene therapy
•Ongoing therapy with valacyclovir that is unable to be stopped due to a medical condition
•Known allergy to valacyclovir
•Concurrent use of other investigational agents.
•* Participants who are currently receiving another investigational drug. Investigational imaging agents or agents used to enhance tumor visibility on imaging or during tumor biopsy/resection should be discussed with the study chairs
•Participants who are currently receiving anti-cancer agents
•Participants with a known disorder that affects their immune system, such as HIV or hepatitis B or C, or an auto-immune disorder requiring systemic cytotoxic or immunosuppressive therapy
+8 more criteria

Locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

June 1, 2026

Primary Completion Date

June 1, 2031

Completion Date

June 1, 2031

Last Updated

March 11, 2026

Enrollment

ESTIMATED participants

Conditions

Recurrent Diffuse Hemispheric Glioma, H3 G34-MutantRecurrent Malignant Brain NeoplasmResectable Brain Neoplasm

Interventions

Ad-hCMV-Flt3L

GENETIC

Ad-hCMV-TK

GENETIC

Biospecimen Collection

PROCEDURE

Magnetic Resonance Imaging

PROCEDURE

Survey Administration

OTHER

Tumor Resection

PROCEDURE

Valacyclovir

DRUG

Contacts

Cancer AnswerLine

CONTACT

1-800-865-1125 CancerAnswerLine@med.umich.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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