Actively Recruiting

Phase 1
Age: 3Years - 39Years
All Genders
NCT06914479

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

Led by University of Michigan Rogel Cancer Center · Updated on 2026-03-11

11

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 39Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 3 to 25 years with a diagnosis of recurrent malignant primary brain tumor after standard therapy
  • Age 26 to 39 years with recurrent diffuse hemispheric glioma, H3 G34-mutant, after standard therapy
  • Body weight at least 10 kg and body surface area greater than 0.5 m²
  • Stable or decreasing corticosteroid dose for at least 3 days before baseline MRI
  • Tumor recurrence must be clinically eligible for surgical resection
  • Ability to understand and sign informed consent and assent as appropriate
  • Willingness to provide archived tumor tissue if available
  • Recovery from acute side effects of prior therapies with specified waiting periods
  • At least 28 days since focal radiation therapy or 150 days since craniospinal irradiation
  • Permitted use of bevacizumab up to 5 doses according to standard dosing
  • Prior use of temozolomide during radiation or dexamethasone allowed
  • Peripheral absolute neutrophil count ≥ 1000/mm³
  • Platelet count ≥ 100,000/mm³ without recent transfusions
  • Adequate kidney function and serum creatinine within normal limits
  • Bilirubin ≤ 2 times upper limit of normal for age
  • Alanine aminotransferase ≤ 3 times upper limit of normal
  • Serum albumin ≤ 2 g/dL
  • Karnofsky or Lansky performance score ≥ 60
  • Agreement to use contraception during and 30 days after treatment for females of child-bearing potential and males
Not Eligible

You will not qualify if you...

  • Not appropriate for tumor tissue resection as determined by neurosurgeon
  • Evidence of spread of disease including leptomeningeal or cerebrospinal fluid dissemination
  • Primary brainstem or spinal tumors
  • History of prior gene therapy
  • Ongoing valacyclovir therapy that cannot be stopped
  • Known allergy to valacyclovir
  • Concurrent use of other investigational agents or anti-cancer drugs
  • Known immune system disorders like HIV, hepatitis B or C, or autoimmune diseases requiring immunosuppressive therapy
  • Uncontrolled infection or systemic illness
  • Current bipolar disorder or major depressive disorder
  • Congenital immune deficiency or acquired autoimmune disease
  • Female participants pregnant or breastfeeding; negative pregnancy test required before therapy
  • Active illicit drug use or alcoholism
  • History of kidney transplant
  • History of allogeneic stem cell transplantation
  • Additional progressing malignancy requiring active treatment within 3 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

C

Cancer AnswerLine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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