Radiation Therapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by David E. Kozono

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial collects biological samples from children with specific cancers who are receiving radiation therapy. The goal is to understand how radiation affects both cancerous and normal cells, which can help improve future treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on corticosteroids, you must be on a stable or decreasing dose for at least 3 days before a baseline MRI scan.

What data supports the effectiveness of the treatment 131I-Metaiodobenzylguanidine (MIBG) for neuroblastoma?

Research shows that 131I-MIBG is an effective treatment for neuroblastoma, with response rates greater than 30% in patients with difficult-to-treat cases. It is considered safe, although it can cause some blood-related side effects.

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Is radiation therapy with 131I-MIBG safe for humans?

Radiation therapy with 131I-MIBG for neuroblastoma is generally considered safe, but it can cause side effects like myelosuppression (a decrease in bone marrow activity) and oral mucositis (painful inflammation and sores in the mouth). Safety measures are in place to protect patients, family caregivers, and medical staff from radiation exposure.

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How is the treatment 131I-MIBG with EBRT different from other treatments for neuroblastoma?

The treatment 131I-MIBG is unique because it specifically targets neuroblastoma cells, delivering radiation directly to the tumor, which may result in more effective and less toxic treatment compared to conventional external-beam radiotherapy. It is particularly used for patients with relapsed or refractory neuroblastoma, where other treatments may not be effective.

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Eligibility Criteria

This trial is for children and young adults with specific types of brain tumors or high-risk neuroblastoma. Participants must meet certain age, health, and diagnostic criteria, have stable vital functions, and not be pregnant or breastfeeding. They should also be enrolled in one of the specified clinical trials related to their condition.

Inclusion Criteria

My bone marrow, kidneys, liver, and nervous system are functioning well.

Availability of tumor tissue, blood and/or CSF biospecimens

I am aged 1-30 with a specific high-risk neuroblastoma and have not had certain treatments.

Exclusion Criteria

Inability to follow the procedures of the study

Pregnancy or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy, including external beam radiation for DMG and 131I-MIBG radiopharmaceutical for neuroblastoma

Varies by individual treatment plan

Multiple visits for radiation sessions

Sample Collection

Collection of biospecimens including blood, CSF, and tumor samples before, during, and after radiation treatment

Concurrent with treatment phase

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

Up to 3 years

Regular follow-up visits for monitoring

Participant Groups

The MCT aims to collect detailed biological data from patients undergoing radiation therapy for tumor treatment. It involves external beam radiotherapy and a radioactive drug called 131I-MIBG to understand how these treatments work against tumors while assessing potential side effects.

Group I: Neuroblastoma Experimental Treatment 1 Intervention

Subjects with high-risk neuroblastoma on COG ANBL1531 (NCT03126916) Arm B

Group II: Diffuse Midline Glioma Experimental Treatment 1 Intervention

Subjects with diffuse midline glioma on PNOC023 (NCT04732065) Arm A or B

131I-Metaiodobenzylguanidine (MIBG) is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as 131I-MIBG for:

• High-risk neuroblastoma

🇪🇺 Approved in European Union as 131I-MIBG for:

• High-risk neuroblastoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

University of California, San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

Brigham and Women's Hospital Lead Sponsor

National Cancer Institute (NCI) Collaborator

Dana-Farber Cancer Institute Collaborator

University of California, San Francisco Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Individualized 131I-mIBG therapy in the management of refractory and relapsed neuroblastoma. [2018] Iodine-131-labelled meta-iodobenzylguanidine (I-mIBG) therapy is an established treatment modality for relapsed/refractory neuroblastoma, most frequently administered according to fixed or weight-based criteria. We evaluate response and toxicity following a dosimetry-based, individualized approach.

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Phase II Trial of MIBG Versus MIBG, Vincristine, and Irinotecan Versus MIBG and Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A Report From NANT Consortium. [2022] Label="PURPOSE"> 131I-metaiodobenzylguanidine (MIBG) is an active radiotherapeutic for neuroblastoma. The primary aim of this trial was to identify which of three MIBG regimens was likely associated with the highest true response rate.

3. United States pubmed.ncbi.nlm.nih.gov

Tumor response and toxicity with multiple infusions of high dose 131I-MIBG for refractory neuroblastoma. [2013] (131)I Metaiodobenzylguanidine ((131)I-MIBG) is an effective targeted radiotherapeutic for neuroblastoma with response rates greater than 30% in refractory disease. Toxicity is mainly limited to myelosuppression. The aim of this study was to determine the response rate and hematologic toxicity of multiple infusions of (131)I-MIBG.

4. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tandem 131I-metaiodobenzylguanidine infusions in relapsed/refractory neuroblastoma. [2013] Targeted radiotherapy with (131) I-Metaiodobenzylguanidine ((131) I-MIBG) is safe and effective therapy for patients with relapsed neuroblastoma, but anti-tumor activity is sometimes transient. The goal of this study was to determine the safety and efficacy of early (

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Whole-Body Radiation Dose on Response and Toxicity in Patients With Neuroblastoma After Therapy With 131 I-Metaiodobenzylguanidine (MIBG). [2020] (131) I-metaiodobenzylguanidine ((131) I-MIBG) is a targeted radiopharmaceutical for patients with neuroblastoma. Despite its tumor-specific uptake, the treatment with (131) I-MIBG results in whole-body radiation exposure. Our aim was to correlate whole-body radiation dose (WBD) from (131) I-MIBG with tumor response, toxicities, and other clinical factors.

6. United States pubmed.ncbi.nlm.nih.gov

Severe oral mucositis after therapeutic administration of [131I]MIBG in a child with neuroblastoma. [2013] The purpose of this report is to document a newly encountered oral side effect of targeted radiotherapy with iodine 131-metaiodobenzylguanidine ([(131)I]MIBG) in the treatment of neuroblastoma.

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric 131I-MIBG Therapy for Neuroblastoma: Whole-Body 131I-MIBG Clearance, Radiation Doses to Patients, Family Caregivers, Medical Staff, and Radiation Safety Measures. [2018] I-metaiodobenzylguanidine (I-MIBG) has been used in the diagnosis and therapy of neuroblastoma in adult and pediatric patients for many years. In this study, we evaluated whole-body I-MIBG clearance and radiation doses received by patients, family caregivers, and medical staff to establish appropriate radiation safety measures to be used in therapy applications.

8. Germany pubmed.ncbi.nlm.nih.gov

Is there a benefit of 131 I-MIBG therapy in the treatment of children with stage 4 neuroblastoma? A retrospective evaluation of The German Neuroblastoma Trial NB97 and implications for The German Neuroblastoma Trial NB2004. [2022] (131)I-meta-iodobenzylguanidine ((131)I-MIBG) therapy has been used in neuroblastoma treatment for many years but its value in high intensive first line treatment protocols is not exactly known.

9. United States pubmed.ncbi.nlm.nih.gov

Phase I dose escalation of 131I-metaiodobenzylguanidine with autologous bone marrow support in refractory neuroblastoma. [2022] The analogue 131I-metaiodobenzylguanidine (MIBG), which is specifically targeted to neuroblastoma cells, may provide more effective and less toxic treatment for neuroblastoma than conventional external-beam radiotherapy. We report a dose escalation study of 131I-MIBG to define dose-limiting toxicity without and with autologous bone marrow support.