Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 been diagnosed with a brain or central nervous system (CNS) tumour that has come back, is getting worse, or has not responded to treatment (except for certain types called diffuse midline gliomas or DIPG).
• The tumour diagnosis must have been confirmed by examining tumour tissue under a microscope, either at the time of first diagnosis or when the tumour came back.
• People who are considered suitable candidates for a small device (called an Ommaya reservoir) placed directly into the tumour cavity, or a type of adjustable brain drain (programmable VP shunt).
• For those being considered for the Ommaya reservoir option, the tumour cavity must measure at least 2 cm x 2 cm on a scan — though having measurable leftover tumour after surgery is not required.
• People with a physical functioning score of 50 or above on age-appropriate scales (Lansky for those aged 16 and under; Karnofsky for those over 16) — people who use a wheelchair but are not confined to bed may still meet this requirement (confirm with trial site).
• People with adequately functioning bone marrow, without having needed a blood transfusion or growth factor injections in the 21 days before treatment begins.
• People with adequately functioning liver, kidneys, and blood clotting levels (confirm specific values with trial site).
• People of childbearing potential who agree to use adequate contraception during the trial.
• People who have adequate neurological function as assessed by the trial team (confirm with trial site).
• People whose last dose of standard chemotherapy was at least 21 days before joining the trial (or at least 42 days for a specific type called nitrosourea).
• People who previously received a drug called bevacizumab must have finished it at least 6 weeks before joining.
• People who previously received a biological or investigational (experimental) treatment must have recovered from any side effects and finished that treatment at least 14 days before joining — or longer if that treatment is known to cause delayed side effects.
• People who received immunotherapy or cell therapy must have finished it at least 12 weeks before joining.
• People who received targeted radiation to the tumour area must have finished it more than 6 weeks before joining; for whole-brain-and-spine radiation, more than 12 weeks must have passed.
• People who had an allogeneic stem cell transplant (from a donor) must be at least 6 months past that transplant with no signs of graft-versus-host disease; for an autologous transplant (using their own cells), at least 3 months must have passed.
• People who have been off growth factor medications (such as filgrastim or erythropoietin) for at least 1 week before joining (or 2 weeks for long-acting versions).
• People taking dexamethasone (a steroid) must have been on a stable or reducing dose for at least 1 week before joining.

Who may not be able to join:

• People whose tumour has spread to multiple locations inside or outside the brain and spinal cord.
• People diagnosed with diffuse midline glioma or DIPG (whether new or recurrent).
• People who are pregnant or breastfeeding.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have an active, uncontrolled infection, or another serious or unstable medical condition.
• People who have a medical condition that makes surgery unsafe.
• People with a known immune system disorder such as HIV, or an autoimmune condition requiring ongoing immune-suppressing medication.
• People with a known bleeding disorder, or who are taking blood-thinning medications or other medications that may increase bleeding risk.
• People who, in the trial team's judgement, may not be able to follow the safety monitoring requirements of the study.
• People with a medical or psychological condition that, in the trial team's opinion, could interfere with their ability to safely participate.

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