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:

General eligibility (applies to all participants):

• People who have been diagnosed with certain brain tumors — either a new diagnosis of specific childhood brain tumors (including medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical teratoid/rhabdoid tumor, or embryonal tumor not otherwise specified), OR imaging evidence of a returning ependymoma with surgery planned or recently completed
• For the new-diagnosis group (Group A): the person must be under 5 years of age at the time of joining
• For the returning ependymoma group (Group B): the person must be older than 1 year and under 30 years of age at the time of joining
• Tumor tissue must be available (or expected to be available after surgery) — approximately 50 mg of fresh or frozen tissue
• A performance score (a measure of how well the person can carry out daily activities) of at least 60 out of 100, as assessed by the medical team
• Blood counts and organ function within acceptable ranges, including adequate levels of white blood cells, platelets, liver function markers, kidney function, and blood oxygen levels (confirm specific values with the trial site)
• The patient (if 18 or older), or their parent or legal guardian (if the patient is a child), must be able to give informed consent
• The patient must be large enough, in the opinion of the study doctor, to safely undergo a blood cell collection procedure called apheresis
• The patient must be considered a suitable candidate for a small device (called a Rickham reservoir) to be placed in the brain, as determined by the study doctor

Before the cell treatment (TSA-T) is given, additional criteria must also be met:

• For Group B participants receiving their first treatment: a laboratory examination of the removed tumor tissue must have confirmed the diagnosis of returning ependymoma
• Performance and organ function levels must still be within the acceptable ranges described above
• Blood counts must have recovered sufficiently from any previous treatments (confirm specific values with the trial site)
• At least 14 days must have passed since the last dose of most chemotherapy or focused radiation, and at least 28 days since whole-brain-and-spine radiation (if applicable)
• The patient must have recovered from any effects of recent surgery
• Group B participants of childbearing potential or who could father a child must agree to use contraception during the trial and for 6 months after the last treatment
• Female participants of childbearing potential in Group B must have a negative pregnancy test
• The patient's neurological condition must have been stable for at least 2 weeks before the first treatment, and for at least 1 week before any later treatments, with steroid doses stable or decreasing — as assessed by the study team
• The Rickham reservoir and its tubing must have been placed more than 7 days before the first treatment
• For patients who have a certain type of brain fluid drainage device (a programmable VP shunt): the device must be able to be safely closed for at least 4 hours, in the opinion of the study doctor

Who may not be able to join:

• People with active, uncontrolled infections
• People with a known HIV infection
• Group A patients whose medulloblastoma has been identified as the SHH subtype
• People with a fever above 38.0°C at the time of the blood cell collection procedure
• People who have received certain experimental immune-based treatments within the 28 days before the planned blood cell collection date
• People who are unable to tolerate the blood cell collection (apheresis) procedure, as determined by the study doctor
• People whose tumor is considered too large or dangerous on imaging — for example, if there are signs of the brain shifting out of position, if the tumor significantly involves the brainstem, or if the study doctor considers the tumor too bulky overall
• People whose disease is getting worse (progressing) before any follow-on treatments (note: the first treatment may still be given, but further treatments would not be available if progression is found before they are due)
• People who have received certain strong immune-suppressing medications within 28 days before treatment
• People taking steroid medications (such as dexamethasone) at a dose higher than 0.05 mg/kg/day
• People who have a non-programmable VP shunt (a specific type of brain fluid drainage device)

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