drugset
drugset / Trial / NCT04743661

131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma

NCT04743661 ↗

Phase 2 Active not recruiting 62 enrolled Pediatric Brain Tumor Consortium Memorial Sloan Kettering Cancer Center · collabNational Cancer Institute (NCI) · collabY-mAbs Therapeutics · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

A Phase 2 study investigating the addition of cRIT 131I-omburtamab to irinotecan, temozolomide, and bevacizumab for patients with recurrent medulloblastoma. A feasibility cohort is included to assess the feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma. Direct intraventricular delivery of radiolabeled tumor-specific antibodies may aid in both the detection and treatment of recurrent disease for these highly specific pediatric patients with recurrent tumors.

Timeline

Start
2022-04-04
Primary completion
2026-03-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Omburtamab Monoclonal antibody 50 mbq Other
Subject Temozolomide Small molecule 150 mg/m2 Oral
Background Acetaminophen Small molecule 15 mg/kg Oral
Background Dexamethasone Small molecule 0.5 mg Oral
Background Dexamethasone Small molecule 1 mg Oral
Background Diphenhydramine Unknown 1 mg/kg Intravenous
Background Liothyronine Small molecule 25 ug Oral
Background Liothyronine Small molecule 50 ug Oral
Background Ondansetron Other / unclassified 0.25 mg/kg Intravenous
Background SSKI Unknown 0.35 ml Oral

Indications

ependymoma medulloblastoma