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NCT04743661 · ClinicalTrials.gov registry record · Phase 2
131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma
A Phase 2 study of Recurrent Medulloblastoma and Recurrent Ependymoma, sponsored by Pediatric Brain Tumor Consortium.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 3
- Study locations
NCT04743661: Active Phase 2 study of Recurrent Medulloblastoma and Recurrent Ependymoma, sponsored by Pediatric Brain Tumor Consortium.
NCT04743661 is a Phase 2 study of Recurrent Medulloblastoma and Recurrent Ependymoma that is active but no longer recruiting, run by Pediatric Brain Tumor Consortium. The registered enrollment target is 62 participants, above the 38-participant average among 12 other Recurrent Medulloblastoma trials with a reported enrollment target (63% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04743661, a Phase 2 study of Recurrent Medulloblastoma and Recurrent Ependymoma, is active but no longer recruiting, sponsored by Pediatric Brain Tumor Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Using the Kaplan Meier method, estimate of event-free survival (EFS) of patients with relapsed medulloblastoma treated with the study regimen. EFS is defined as the interval of time between enrollment on the study and the minimum date of documentation of progressive disease, death due to any cause, subsequent malignancy or date of last follow-up.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG Omburtamab I-131
- DRUG Liothyronine
Study Locations (3)
California
- Children's Hospital Los Angeles - Los Angeles
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04743661 still lists
NCT04743661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, above the 38-participant average among 12 other Recurrent Medulloblastoma trials with a reported enrollment target (63% higher).
The record links to 2 conditions, with Recurrent Medulloblastoma appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04743661 reports a single indexed study location in California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT04743661 about?
NCT04743661 is a clinical study titled "131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma". 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. Direc...
What is the current status of trial NCT04743661?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2022-04-04. Estimated completion is 2027-09-30.
What conditions does trial NCT04743661 study?
This clinical trial studies the following conditions: Recurrent Medulloblastoma, Recurrent Ependymoma.
What interventions are being tested in trial NCT04743661?
The interventions under investigation include: Bevacizumab (DRUG), Temozolomide (DRUG), Irinotecan (DRUG), Omburtamab I-131 (DRUG), Liothyronine (DRUG).
Who is sponsoring clinical trial NCT04743661?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04743661 being conducted?
This trial has 3 study locations across California, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04743661's enrollment target sits among peer trials
62 4th of 12 higher than 9 of 12 other Recurrent Medulloblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Medulloblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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