177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma

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.