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Biological Response Modifier

Radioimmunotherapy for Recurrent Pediatric Brain Cancer

Q: What is the projected scope of this test group?

Recruitment for this clinical trial has ceased. It was originally posted on April 4th, 2022 and received its last update on November 2nd, 2022. If you are looking for other trials, 1134 studies for <a href="https://www.withpower.com/clinical-trials/medulloblastoma">medulloblastoma</a> and 1363 anti-emetic trials are still recruiting patients.

Q: What medications are available to control nausea and vomiting that have been cleared by the FDA?

While there is some evidence to support the safety of anti-emetics, it is still in Phase 2 of clinical trials and has not been proven effective yet.

Q: What vomiting and nausea does this medication help relieve?

while most commonly used to treat recurrent <a href="https://www.withpower.com/clinical-trials/cervical-cancer">cervical cancer</a>, anti-emetics have also been shown to help with other conditions like synovitis, neoplasm metastasis, and ophthalmia.

Q: Could you please explain the goals of this research?

The purpose of this study is to observe the feasibility of a new treatment for ependymoma over the course of two years. Additionally, we will also be looking at secondary outcomes such as the percentage of patients who show B7H3 reactivity, event-free survival, and overall survival.

Q: Are we currently able to sign people up for this clinical trial?

No, this particular trial is not recruiting patients right now. However, this may change in the future as the study's most recent update was on November 2nd, 2022. There are 2497 other trials that are recruiting patients at this present moment.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am younger than 22 years old.

Select...

I am under 22 years old.

Select...

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

Select...

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

Select...

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

Select...

My tumor reacts to B7H3 (CD276).

Select...

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

Select...

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

Select...

I had Hep C but have been treated and cured.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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.

Select...

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

Select...

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

Select...

My cancer tests positive for B7H3.

Select...

My medulloblastoma has returned or worsened after radiation therapy.

Select...

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

Select...

I have a device installed for brain treatment.

Select...

I am under 22 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

~5280

Dexamethasone

2007

Completed Phase 4

~2590

Liothyronine

2015

Completed Phase 3

~310

Irinotecan

2017

Completed Phase 4

~2680

Temozolomide

2010

Completed Phase 3

~1930

Antihistamine

2016

Completed Phase 3

~220

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

Y-mAbs TherapeuticsIndustry Sponsor

25 Previous Clinical Trials

1,495 Total Patients Enrolled

1 Trials studying Medulloblastoma

2 Patients Enrolled for Medulloblastoma

Y-mAbs Therapeutics, IncUNKNOWN

3 Previous Clinical Trials

429 Total Patients Enrolled

Pediatric Brain Tumor ConsortiumLead Sponsor

37 Previous Clinical Trials

1,520 Total Patients Enrolled

9 Trials studying Medulloblastoma

545 Patients Enrolled for Medulloblastoma

Media Library

Bevacizumab (Biological Response Modifier) Clinical Trial Eligibility Overview. Trial Name: NCT04743661 — Phase 2

Medulloblastoma Research Study Groups: Recurrent Medulloblastoma, Recurrent Ependymoma

Medulloblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT04743661 — Phase 2

Bevacizumab (Biological Response Modifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743661 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the projected scope of this test group?

"Recruitment for this clinical trial has ceased. It was originally posted on April 4th, 2022 and received its last update on November 2nd, 2022. If you are looking for other trials, 1134 studies for medulloblastoma and 1363 anti-emetic trials are still recruiting patients."

Answered by AI

What medications are available to control nausea and vomiting that have been cleared by the FDA?

"While there is some evidence to support the safety of anti-emetics, it is still in Phase 2 of clinical trials and has not been proven effective yet."

Answered by AI

What vomiting and nausea does this medication help relieve?

"while most commonly used to treat recurrent cervical cancer, anti-emetics have also been shown to help with other conditions like synovitis, neoplasm metastasis, and ophthalmia."

Answered by AI

Could you please explain the goals of this research?

"The purpose of this study is to observe the feasibility of a new treatment for ependymoma over the course of two years. Additionally, we will also be looking at secondary outcomes such as the percentage of patients who show B7H3 reactivity, event-free survival, and overall survival."

Answered by AI

Are we currently able to sign people up for this clinical trial?

"No, this particular trial is not recruiting patients right now. However, this may change in the future as the study's most recent update was on November 2nd, 2022. There are 2497 other trials that are recruiting patients at this present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma

2022. "131I-Omburtamab, in Recurrent Medulloblastoma and Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04743661.

All > Ependymoma > Medulloblastoma