What side effects are associated with this type of intervention?

The most common treatments for Neuroblastoma include chemotherapy, radiation therapy, and surgery. Chemotherapy can cause side effects such as fatigue, nausea, vomiting, hair loss, and increased risk of infections due to lowered white blood cell counts. Radiation therapy, which is a focus of the Biospecimen Collection and Annotation trial, can lead to side effects including skin irritation, fatigue, and potential long-term effects such as growth delays, hormonal imbalances, and increased risk of secondary cancers. Surgery, while generally safe, can result in pain, infection, and complications related to anesthesia. Long-term follow-up is essential to monitor and manage these potential side effects.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Neuroblastoma have included various chemotherapy agents and biologics. Treatments often involve a combination of high-dose chemotherapy, radiation therapy, and stem cell rescue. For instance, drugs like cisplatin, cyclophosphamide, and topotecan have been used in conjunction with radiation therapy to treat high-risk Neuroblastoma. Additionally, biologics such as dinutuximab, an anti-GD2 monoclonal antibody, have been approved for use in combination with other treatments to improve outcomes in pediatric patients with high-risk Neuroblastoma.

What other types of research exist?

Promising novel alternatives for understanding the biological mechanisms of radiation therapy in neuroblastoma patients include: 1) Molecular Characterization Trials (MCT) that collect and deeply annotate biospecimens before, during, and after radiation therapy; 2) Bioinformatics-guided discovery of novel post-translational modifications (PTMs) from proteomic data; and 3) The use of high-throughput digital systems like the NanoString nCounter™ for validating prognostic multi-gene signatures. These approaches provide comprehensive insights into tumor biology and treatment efficacy.

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Radiation

Radiation Therapy for Neuroblastoma

N/A

Recruiting

Led By David Kozono, MD, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include damage to healthy tissues due to radiation exposure, thyroid issues from radioactive iodine (131I-MIBG), fatigue, nausea, blood count changes leading to increased infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Event-free survival by DNA damage response

Event-free survival by tumor DNA alterations

Event-free survival by tumor heterogeneity

Secondary study objectives

Proportion of patients with serious adverse events by DNA damage response

Trial Design

2Treatment groups

Experimental Treatment

Group I: NeuroblastomaExperimental Treatment1 Intervention

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

Group II: Diffuse Midline GliomaExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

External beam radiotherapy

2004

Completed Phase 2

~130

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neuroblastoma include chemotherapy, radiation therapy, and molecularly targeted therapies. Chemotherapy, using agents like cisplatin and etoposide, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Radiation therapy targets the tumor with high-energy rays to destroy cancer cells while sparing surrounding healthy tissue. Molecularly targeted therapies, such as those inhibiting specific pathways like the sonic hedgehog pathway, aim to block the growth and spread of cancer cells by interfering with specific molecular targets involved in tumor growth. Understanding these mechanisms is crucial for Neuroblastoma patients as it allows for the development of more effective and less toxic treatments, improving survival rates and quality of life.

Understanding regulation of cell growth in childhood brain tumors.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,953 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,648 Patients Enrolled for Neuroblastoma

Brigham and Women's HospitalLead Sponsor

1,653 Previous Clinical Trials

11,490,988 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,100 Previous Clinical Trials

353,050 Total Patients Enrolled

10 Trials studying Neuroblastoma

3,796 Patients Enrolled for Neuroblastoma

~31 spots leftby Aug 2028

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