Phase 1 Brain Cancer Trial, Recruiting NCT06914479 Sponsor: University of Michigan Rogel Cancer Center Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT06914479
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 3 and 25 years old and have been diagnosed with a cancerous brain tumor that has come back, gotten worse, or stopped responding to treatment, and you have already completed standard first-line treatment
  • You are between 26 and 39 years old and have been diagnosed with a specific type of brain tumor called "diffuse hemispheric glioma, H3 G34-mutant" (confirm with trial site) that has come back or progressed, and you have already completed standard first-line treatment
  • You weigh at least 10 kg (about 22 pounds) and have a body surface area above a certain minimum size (confirm with trial site)
  • If you are taking steroid medications, your dose has been stable or decreasing for at least 3 days before your baseline MRI scan
  • Your doctors have determined that surgery to remove the returned/progressed tumor is medically appropriate for you
  • You or your parent/guardian are willing and able to sign a consent form agreeing to participate
  • You are willing to provide stored tumor tissue samples if they are available
  • You have recovered from the side effects of any previous cancer treatments, and enough time has passed since your last treatment (the exact waiting period depends on the type of treatment — confirm with trial site)
  • If you previously had radiation therapy, at least 28 days have passed since focused radiation, or at least 150 days since full brain-and-spine radiation
  • Your blood cell counts and organ function (blood, kidney, and liver) meet specific healthy ranges as measured by blood tests (confirm exact values with trial site)
  • You have a performance/activity level score of 60 or higher on a standard medical scale, meaning you are able to care for yourself to a reasonable degree (confirm with trial site)
  • If you are able to become pregnant or can father a child, you agree to use effective contraception during the study and for 30 days after your last dose of study treatment

Who may not be able to join:

  • Your neurosurgeon has decided that surgery to remove the tumor is not appropriate for you
  • Your cancer has spread widely, including into the fluid surrounding the brain or spinal cord
  • Your tumor started in the brainstem or spinal cord
  • You have previously received any type of gene therapy
  • You are currently taking valacyclovir (an antiviral medication) and cannot stop it for a medical reason
  • You have a known allergy to valacyclovir
  • You are currently taking part in another clinical trial or receiving another experimental drug
  • You are currently receiving any other cancer treatment
  • You have a known condition that affects your immune system, such as HIV, hepatitis B or C, or an autoimmune disease requiring strong immune-suppressing medication
  • You have an infection or other serious illness that is not under control
  • You currently have a diagnosis of bipolar disorder or major depressive disorder
  • You have a condition present from birth, or one you developed, that weakens your immune system
  • You are pregnant or breastfeeding, or you have a positive pregnancy test before starting the study
  • You are actively using illegal drugs or have been diagnosed with alcoholism
  • You have had a kidney transplant in the past
  • You have had a bone marrow or stem cell transplant from a donor in the past
  • You have another cancer (separate from your brain tumor) that is still growing or being actively treated within 3 years of starting this study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
University of Michigan Rogel Cancer Center
Registry
ClinicalTrials.gov
Start date
22 May 2026
Est. completion
1 May 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose limiting toxicity (DLT)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov