The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent/refractory medulloblastoma or another type of cancer with CNS metastases.
Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.
Patients must have recurrent or refractory disease with CNS parenchymal and/or leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.
Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.
Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.
Patients with obstructive or symptomatic communicating hydrocephalus.
Patients with an uncontrolled life-threatening infection.
Cardiac, pulmonary, and gastrointestinal system toxicity should all be < grade 2
Patients with grade 4 hearing loss are excluded
Sequential
25 mCi 177Lu- DTPA-omburtamab
Biological/VaccineThe dose of DTPA-omburtamab will be decided by the dose escalation design
Number of participants with toxicities
To determine safety of up to 2 cycles of cRIT with 177Lu-DTPA-omburtamab treatment in pediatric patients graded according to CTCAE version 5
Maximum Tolerated Dose/MTD
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of a single injection of cRIT with 177Lu-DTPA-omburtamab in pediatric patients.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Y-mAbs Therapeutics
Collaborator
