Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2021-02-03
Brief Title:
131I-Omburtamab in Recurrent Medulloblastoma and Ependymoma
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients With Recurrent Medulloblastoma and Ependymoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Stratum 1 This is a phase 2 single-arm open-label study that will define event-free survival EFS and overall survival OS following therapy with irinotecan temozolomide bevacizumab and compartmental intraOmmaya radioimmunotherapy cRIT 131I-omburtamab in patients with recurrent medulloblastoma Patients with recurrent medulloblastoma will undergo surgery if feasible prior to study entry followed by Induction Chemotherapy with irinotecan temozolomide and bevacizumab on study as per the Childrens Oncology Group COG trial ACNS0821 Following 2 or 4 courses of chemotherapy and if radiographic disease status is stable or improved patients may continue to Radioimmunotherapy to receive 2 therapeutic doses 50 mCi each of cRIT 131I-omburtamab Following Radioimmunotherapy patients may resume to Maintenance Chemotherapy with irinotecan temozolomide and bevacizumab for up to 12 total courses of chemotherapy or until disease progression whichever occurs sooner The primary comparison for this study will be the medulloblastoma cohort treated on ACNS0821 on the irinotecan temozolomide bevacizumab arm N52
Stratum 2 This is a feasibility cohort The primary objective is to assess feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma and to assess dosimetry Patients must have progressed after initial surgery radiation therapy or other therapies Patients will undergo surgery if feasible prior to study entry with the goal of achieving stable or better disease Tumors archived or new will be tested for B7H3 prior to enrollment If positive patients will enroll on Stratum 2 and receive one dosimetry dose 2 mCi of cRIT 131I-omburtamab with nuclear medicine scintigraphy typically using 3 whole-body planar gamma camera imaging and at least 1 head SPECT scan or SPECTCT using SPECT during the Dosimetry Course 14 days in length Following the Dosimetry Course and within 2 weeks of the dosimetry dose patients may continue to Radioimmunotherapy to receive 2 therapeutic doses 50 mCi each of cRIT 131I-omburtamab
Stratum 2 This is a feasibility cohort The primary objective is to assess feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma and to assess dosimetry Patients must have progressed after initial surgery radiation therapy or other therapies Patients will undergo surgery if feasible prior to study entry with the goal of achieving stable or better disease Tumors archived or new will be tested for B7H3 prior to enrollment If positive patients will enroll on Stratum 2 and receive one dosimetry dose 2 mCi of cRIT 131I-omburtamab with nuclear medicine scintigraphy typically using 3 whole-body planar gamma camera imaging and at least 1 head SPECT scan or SPECTCT using SPECT during the Dosimetry Course 14 days in length Following the Dosimetry Course and within 2 weeks of the dosimetry dose patients may continue to Radioimmunotherapy to receive 2 therapeutic doses 50 mCi each of cRIT 131I-omburtamab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PBTC-058 | OTHER | None | None |
| NCI-2021-00773 | REGISTRY | None | None |
| PBTC-058 | OTHER | None | None |
| UM1CA081457 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA081457 |