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.
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 Children's 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 (N=52).
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 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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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