About this trial
This study looks at a new way to deliver the drug Topotecan directly to the brain for patients with recurrent malignant glioma that has the Isocitrate Dehydrogenase mutation. The main goal is to ensure this method is safe. Researchers also want to see how well the drug spreads in the brain and how the tumors respond to this delivery method. The treatment involves using a special pump that sends the drug directly to the tumor over several days, with regular health monitoring throughout the process.
The trial's ID is NCT06666712. It is in Phase 1, which means the study is assessing how safe the treatment is and how well it works. The trial is regulated by the FDA and aims to include 6 participants.
Who can join
Adults aged 18 and older can join if they have recurrent malignant glioma with specific genetic features and have had previous treatment. Participants must be able to give informed consent and be medically fit for surgery. Certain health issues may prevent participation, such as specific infections or previous treatments with Topotecan. The trial team will confirm eligibility before anyone joins.
Conditions
Brain Tumor, Recurrent, Malignant Glioma (WHO Grade III or IV), IDH1/IDH2 Mutation
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will receive Topotecan through a special delivery method called Convection-Enhanced Delivery. This involves four infusions of the drug over a period of about a month. Everyone in the study will get the same treatment. Health will be closely monitored during and after the infusions.
Where
This trial is running at 1 location in the United States. It is currently recruiting.
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York