Early Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a brain tumor located in the upper part of the brain (not the brainstem or deep structures) that imaging suggests is a type of glioma (grade II to IV), and where surgeons plan to remove all or part of the tumor.
• People whose tumor has been confirmed as a grade II to IV glioma either during surgery (via a quick tissue test) or through a previous biopsy or surgery.
• People who are 18 years of age or older.
• People who are reasonably able to carry out daily activities, as measured by a standard medical scoring scale (a score of 60 or above on the Karnofsky Performance Scale — confirm with trial site if unsure what this means).
• People whose blood, liver, and kidney function results fall within acceptable ranges as defined by the trial (specific blood test thresholds apply — the trial site can confirm these).
• People whose neurosurgeon has assessed them and determined that the small implantable device used in this trial can safely be placed given their tumor's size, location, and medical history.
• People who are taking medications that affect a group of liver enzymes called CYP450, since the trial considers this not to be a concern given how the device works.
• Women who are able to become pregnant and who agree to a pregnancy blood test within 48 hours before joining, and who agree to use reliable contraception throughout the trial. Men participating must also agree to use reliable contraception throughout the trial.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy or radiation therapy within the past 4 weeks (or 6 weeks for a specific type of chemotherapy called nitrosoureas), or who are still experiencing side effects from previous cancer treatment.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have a known history of allergic reactions to substances similar to those used in this trial's device or medications.
• People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, an irregular heartbeat, or a mental health or personal situation that could make it difficult to follow the trial's requirements.
• Women who are pregnant, since the medications released by the device could harm a developing baby. Women who are breastfeeding would need to stop breastfeeding for 14 days after the device is removed if they participate.
• People whose tumor is smaller than 5 cm³ in volume.
• People whose tumor is located in deep brain structures, such as the thalamus or brainstem.
• People with a bleeding or blood-clotting disorder that cannot be corrected and that increases the risk of complications during surgery.
• People who have significant health risk factors — such as a high risk of blood clots, pulmonary embolism, stroke, or heart attack — that make it unsafe to temporarily stop blood-thinning medications before surgery, in line with relevant medical guidelines.

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