Early Phase 1 Brain Cancer Trial, Recruiting NCT05423210 Sponsor: Stony Brook University Condition: Brain Cancer
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Early Phase 1 Brain Cancer Trial, Recruiting

NCT05423210
Recruiting Early 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:

  • People who have been diagnosed with glioblastoma multiforme, a type of brain tumour classified as WHO Grade IV (the most serious grade)
  • People whose doctors have determined they are suitable for surgery, with the goal of removing more than 80% of the tumour
  • People who have a negative pregnancy test
  • People whose general physical functioning is rated at a certain level or above (this is measured using a medical scale called ECOG — confirm with trial site what this means for your situation)
  • People whose tumour measures 3.5 cm or smaller
  • People whose liver, kidneys, and other organs are working well enough to safely participate
  • People who have tested negative for HIV, Hepatitis B, Hepatitis C, and tuberculosis

Who may not be able to join:

  • People who have already had surgery (full or partial tumour removal) or radiation therapy for this tumour
  • People whose cancer has spread to the lining of the brain or spinal cord, or whose disease affects multiple areas of the brain or both sides of the brain at once
  • People considered to be at higher risk of serious neurological decline (confirm with trial site)
  • People who are taking high doses of steroid medicines, either by injection or by mouth, or more than 8 mg per day of a steroid called dexamethasone
  • People experiencing pain from the tumour that is not well controlled
  • People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month
  • People with uncontrolled high calcium levels in the blood
  • People with a history of autoimmune disease or a condition that weakens the immune system
  • People with a history of certain types of lung scarring or inflammation, or who currently have active lung inflammation
  • People with serious heart or blood vessel disease
  • People who have had another type of cancer within the past year
  • People who have had a severe infection within the 4 weeks before starting the study treatment
  • People who have previously had a stem cell or organ transplant from a donor
  • People who have previously been treated with certain immune-boosting therapies called CD137 agonists or immune checkpoint treatments
  • People currently taking medicines that stimulate the immune system
  • People currently taking medicines that suppress or reduce the activity of the immune system

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 14 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Alexander Stessin, MD, Stony Brook Cancer Center

Phone: 631-508-2212

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
Early Phase 1
Sponsor
Stony Brook University
Registry
ClinicalTrials.gov
Start date
25 October 2022
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants who progress/relapse after surgical resection; Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

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: 14 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