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

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 neede

Trial Details

NCT ID
NCT06914479
Phase
PHASE1
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Ad-hCMV-Flt3L
  • Ad-hCMV-TK
  • Biospecimen Collection
  • Magnetic Resonance Imaging
  • Survey Administration
  • Tumor Resection
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility 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, o…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Brain Cancer Trials on Trialify →