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131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma

StatusActive, Not Recruiting
PhasePhase 2
Started2022-04-04
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 15 times since 2021-02-03; most recent filed 2026-07-24. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-07-24
Amendment Study Status v15
2026-02-03
Amendment Study Status v14
2024-08-02
Amendment Study Status, Document Section v13
2024-08-01
Amendment Study Status, Document Section v12
2024-03-27
Amendment Study Identification, Study Status v11
2024-01-18
Amendment Study Status v10
2023-03-07
Amendment Study Status, Study Description, Eligibility, Contacts/Locations v9
2023-01-09
Amendment Study Status v8
2022-11-02
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
2022-08-25
Amendment Study Status, Contacts/Locations v6
2022-04-07
Amendment Study Status v5
2022-03-29
Amendment Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v4
2022-01-06
Amendment Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v3
2021-12-01
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
2021-09-23
Amendment Study Status, Study Description, Arms and Interventions, Eligibility v1
2021-02-03
Original filing
Trial Details
NCT Number NCT04743661
Lead Sponsor Pediatric Brain Tumor Consortium
Collaborators: National Cancer Institute (NCI), Memorial Sloan Kettering Cancer Center, Y-mAbs Therapeutics
Conditions Recurrent Medulloblastoma, Recurrent Ependymoma
Enrollment 62 participants
Start Date 2022-04-04
Primary Completion 2026-04-01 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-28