Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT04167618
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of medulloblastoma.
* SHH, Group 3, or Group 4 according to World Health Organisation (WHO) 2016 classification.
* Recurrent (maximum of 2 recurrences for Part 1 and 1 recurrence for Part 2) or refractory to frontline therapy. Prior frontline or second line therapy may involve surgery, craniospinal irradiation, stereotactic radiosurgery, and multi-agent chemotherapy regimens.
* Have refractory disease, focal or multifocal recurrent disease, or pure leptomeningeal disease. Cytological or radiographic remission is allowed; however, not simultaneously.
* Performance status score of 50 to 100 on Lansky (less than 16 years) or Karnofsky (16 years or older) scales.
* Life expectancy of at least 3 months, as judged by the Investigator.
* Acceptable hematological status and liver and kidney function.
Exclusion Criteria:
* Obstructive or symptomatic communicating hydrocephalus as determined by Ommaya patency/cerebrospinal fluid (CSF) flow study.
* Residual disease (nodular or linear) measuring \> 15 mm in the smallest diameter.
* Ventriculoperitoneal shunts without programmable valves. Ventriculo-atrial or ventriculo-pleural shunts.
* Grade 4 nervous system disorder. Stable neurological deficits (due to brain tumor or surgery) or hearing loss are allowed.
* Uncontrolled life-threatening infection.
* Received radiation therapy less than 3 weeks prior to the screening visit.
* Received systemic or intrathecal cytotoxic chemotherapy or intrathecal immunotherapy (corticosteroids not included) less than 3 weeks prior to the screening visit.
* Received any prior anti-B7-H3 treatment.
* Non-hematologic organ toxicity Grade 3 or above; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity.
* Other significant disease or condition that in the investigator's opinion would exclude the patient from the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
19 Years
Study:
NCT04167618
Study Brief:
Protocol Section:
NCT04167618