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Biological Response Modifier

Radioimmunotherapy for Recurrent Pediatric Brain Cancer

Phase 2

Waitlist Available

Led By Matthias Karajannis, MD, MS

Research Sponsored by Pediatric Brain Tumor Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Organ Function - Patients must have peripheral absolute neutrophil count (ANC) ≥ 1 x 10^9/ L, platelet count ≥ 100 x 10^9/ L, hemoglobin ≥ 8.0 g/dL, serum creatinine based on age/gender, total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), ALT (SGPT) and AST (SGOT) < 5 x institutional upper limit of normal (ULN), HIV Infected Individuals - Patients who are known to be Human immunodeficiency virus (HIV)-infected must be on effective anti-retroviral therapy with undetectable viral load within 6 months prior to study enrollment.

Patients must be < 22 years of age at the time of enrollment.

Must not have

Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.

Patients must not have previously received the combination of bevacizumab, irinotecan, and temozolomide therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to deliver a tumor-specific antibody directly to the brain in order to improve detection and treatment of recurrent brain tumors in children.

Who is the study for?

This trial is for patients under 22 years old with recurrent, progressive, or refractory medulloblastoma or ependymoma. They must have a performance score of ≥50%, be off growth factors for at least a week, and not have severe organ dysfunction. HIV/Hep B/C patients must be on effective therapy with undetectable viral load. Participants need confirmed tumor reactivity to B7H3 and should agree to use birth control.

What is being tested?

The study tests the addition of cRIT 131I-omburtamab (a radiolabeled antibody) to chemotherapy drugs irinotecan, temozolomide, and bevacizumab in children with recurrent brain tumors. It explores if direct delivery into the cerebrospinal fluid can better detect/treat these conditions compared to standard treatments.

What are the potential side effects?

Possible side effects include reactions related to radioimmunotherapy such as nausea, vomiting (managed by anti-emetics), allergic responses (countered by antihistamines), thyroid issues controlled by Liothyronine/SSKI, blood count changes due to dexamethasone, and potential bleeding risks managed by avoiding certain medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am younger than 22 years old.

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I am under 22 years old.

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My ependymoma cancer came back or didn't respond after radiation therapy.

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My medulloblastoma has come back or isn't responding to treatment.

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I have chronic Hepatitis B but it's undetectable with treatment.

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My tumor reacts to B7H3 (CD276).

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My cancer can be seen on an MRI, or I have cancer cells in my CSF.

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I have or will have a device installed for my brain cancer treatment.

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I had Hep C but have been treated and cured.

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My ependymoma cancer has come back or is not responding to treatment.

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My blood counts and liver function are within normal ranges, and my high blood pressure is under control.

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My ependymoma cancer has come back or is not responding to treatment.

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I am HIV positive, on effective treatment, and my viral load is undetectable.

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I haven't had major radiation to my head, whole body, or more than half of my pelvis or spine in the last 6 months. Any tumor to be measured hasn't been radiated in the last 3 months.

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My medulloblastoma has come back or isn't responding to treatment.

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I received my last monoclonal antibody treatment over 3 weeks ago and have recovered from its side effects.

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My cancer tests positive for B7H3.

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My medulloblastoma has returned or worsened after radiation therapy.

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I've recovered from side effects of my last antibody treatment, taken 3 weeks ago.

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I have a device installed for brain treatment.

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I am under 22 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking any cancer treatment or experimental drugs.

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I have never been treated with bevacizumab, irinotecan, and temozolomide together.

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I have not had a stroke, heart attack, severe heart issues, or major blood vessel problems in the last 6 months.

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I am not breastfeeding or I agree to stop breastfeeding to join the study.

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I do not have any major health issues unrelated to my cancer.

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I do not have any known blood clotting disorders.

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I am not currently taking NSAIDs, clopidogrel, dipyridamole, or high-dose aspirin.

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I do not have any known bleeding disorders.

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I do not have severe or unmanaged heart rhythm problems.

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I do not have any serious wounds, ulcers, or unhealed bone fractures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

2-year event free survival (EFS) in the Recurrent Medulloblastoma Cohort

Percentage of Patients who met feasibility criteria in the Recurrent Ependymoma Cohort

Secondary study objectives

Estimate of Mean Absorbed Radiation Dose

Event free survival (EFS) for Recurrent Ependymoma

Number of Recurrent Medulloblastoma and Ependymoma Participants with Grade 3 or higher 131I-omburtamab - Related Adverse Events as Assessed by CTCAE v5.0

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Recurrent MedulloblastomaExperimental Treatment10 Interventions

This arm aims to estimate 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 will receive 2 therapeutic doses of 50 mCi cRIT 131I-omburtamab during Radioimmunotherapy. 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.

Group II: Recurrent EpendymomaExperimental Treatment7 Interventions

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. Tumor tissue (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) of cRIT 131I-omburtamab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Dexamethasone

2007

Completed Phase 4

~2650