Phase 1 Brain Cancer Trial, Recruiting NCT07076498 Sponsor: M.D. Anderson Cancer Center Condition: Brain Cancer
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Phase 1 Brain Cancer Trial, Recruiting

NCT07076498
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 (or your child) must be at least 36 months (3 years) old
  • You have been newly diagnosed with a specific type of brain tumor called diffuse midline glioma (DMG) with a particular genetic change (H3 K27M), or a brain stem tumor called DIPG that has been confirmed by imaging or biopsy
  • You must have already completed standard radiation therapy between 4 and 8 weeks before joining the study
  • The tumor must be between 1.0 cm and 4.0 cm in size and reachable by surgery, as shown on an MRI scan (for certain tumors above 4.0 cm located in the upper brain, eligibility may still be possible if surgery can reduce the size — confirm with trial site)
  • Any side effects from previous treatments must have fully gone away before joining
  • If you previously received a specific antibody treatment (such as bevacizumab), your last dose must have been at least 21 days ago
  • If you received chemotherapy (temozolomide), your last dose must have been at least 4 weeks ago
  • Your blood counts, kidney function, and liver function must be within acceptable ranges (the trial team will check this with blood tests)
  • Children under 16 must score at least 60 on a scale measuring their ability to do daily activities; people 16 and older must also meet a similar functioning threshold
  • Women who could become pregnant and men must agree to use an approved form of birth control during the study
  • You or your legal guardian must be willing and able to sign a consent form agreeing to participate

Who may not be able to join:

  • People who have previously taken part in another experimental drug trial
  • People who have untreated fluid build-up in the brain causing symptoms (hydrocephalus)
  • People whose tumor appears unusual on imaging and has not been confirmed by biopsy to have the specific genetic change (H3 K27M)
  • People whose tumor is located in the spinal cord rather than the brain
  • People with an active serious infection, very low white blood cell counts, or other medical conditions that make surgery unsafe
  • Women who are pregnant or breastfeeding
  • People who were diagnosed with brain inflammation (encephalitis) or a brain infection within the last 12 weeks
  • People currently being treated for brain inflammation, brain infection, or multiple sclerosis
  • People whose tumor is positioned in a way that would require the treatment to be delivered through the fluid-filled spaces of the brain (ventricles)
  • People currently taking immune-suppressing medications, including steroids (except for low-dose replacement steroids or inhaled/topical treatments), within at least 1 week of joining
  • People known to have HIV or a known immune deficiency condition
  • People with an active herpes infection that is causing symptoms
  • People currently taking any anti-herpes medications (such as acyclovir or valacyclovir) or other immune-suppressing drugs
  • People with another cancer that could affect the safety or results of this study
  • People currently receiving any other cancer treatment or experimental drug
  • People who cannot safely have an MRI scan or receive MRI contrast dye
  • People who have received a live vaccine within 30 days before the planned treatment

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 27 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.

Contact this trial

Principal Investigator: Gregory Kane Friedman Friedman, MD, M.D. Anderson Cancer Center

Phone: 713-835-4467

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
23 April 2026
Est. completion
31 December 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Adverse Events (AEs)

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: 27 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