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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06914479
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Diffuse Hemispheric Glioma, H3 G34-Mutant
  • Recurrent Malignant Brain Neoplasm
  • Resectable Brain Neoplasm

Eligibility Criteria

Sex
ALL
Age
3 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Ad-hCMV-Flt3L — GENETIC
    Given via injection
  • Ad-hCMV-TK — GENETIC
    Given via injection
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Survey Administration — OTHER
    Ancillary studies
  • Tumor Resection — PROCEDURE
    Undergo standard of care tumor resection
  • Valacyclovir — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
May 22, 2026
Status verified
May 2026
Primary completion
May 31, 2031
Completion
May 31, 2031

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (AdV-HSV1-TK , AdV-Flt3L and valacyclovir)
    Patients undergo standard of care tumor resection and receive AdV-HSV1-TK and AdV-Flt3L via multiple injections over 3-5 minutes each to areas around the tumor. One to three days after surgery, patients receive valacyclovir PO TID on days 1-14 of each cycle. Cycles repeat every 12 weeks for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients may also receive standard of care radiation therapy starting on day 21. Patients undergo MRI and blood sample collection throughout the study.

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: Up to day 21 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109
Andrea T. Franson
[email protected]
800-865-1125
Andrea T. Franson (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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