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Radioactive Agent

Radioactive MIBG for Neuroblastoma

Phase 2

Recruiting

Led By Ellen Basu, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines

Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing how effective and safe a radioactive form of a drug called MIBG is for patients with neuroblastoma, pheochromocytoma, and paraganglioma that have not responded to other treatments.

Who is the study for?

This trial is for patients with recurrent or resistant neuroblastoma, malignant pheochromocytoma, or paraganglioma. Participants must be over 1 year old, have a life expectancy of at least eight weeks, and be able to follow radiation safety procedures. They need stored stem cells for re-infusion post-treatment. Pregnant women and those unable to comply with safety protocols are excluded.Check my eligibility

What is being tested?

The study tests the activity and safety of Iodine I 131 Metaiodobenzylguanidine (131 I-MIBG) in treating certain cancers that haven't responded well to other treatments. It aims to understand how effective this treatment is against these specific conditions.See study design

What are the potential side effects?

Potential side effects may include damage to major organs like kidneys, heart, liver, lungs; gastrointestinal issues; neurological toxicity; hearing loss (up to grade 3); as well as risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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My neuroblastoma diagnosis is confirmed by specific tests and criteria.

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My cancer has grown, come back, or didn't fully respond to standard treatments.

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My neuroblastoma shows up on MIBG scans.

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It's been over 2 weeks since my last biological therapy and 3 weeks since my last chemotherapy.

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I have been diagnosed with a malignant pheochromocytoma or paraganglioma.

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I have my stem cells stored for treatment after MIBG therapy.

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I am between 1 and 21 years old and can follow safety rules during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Response (complete or partial)

Secondary outcome measures

Correlation between tumor self-absorbed dose and response and tumor volume decrease

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadiationExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iobenguane I 131

2007

Completed Phase 2

~60

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,692 Total Patients Enrolled

49 Trials studying Neuroblastoma

5,591 Patients Enrolled for Neuroblastoma

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,705 Total Patients Enrolled

205 Trials studying Neuroblastoma

53,484 Patients Enrolled for Neuroblastoma

Ellen Basu, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

56 Total Patients Enrolled

1 Trials studying Neuroblastoma

56 Patients Enrolled for Neuroblastoma

Media Library

Iobenguane I 131 (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00107289 — Phase 2

Neuroblastoma Research Study Groups: Radiation

Neuroblastoma Clinical Trial 2023: Iobenguane I 131 Highlights & Side Effects. Trial Name: NCT00107289 — Phase 2

Iobenguane I 131 (Radioactive Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00107289 — Phase 2

Frequently Asked Questions

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

Is this experiment taking on new participants?

"Data on clinicaltrials.gov confirms that the team is still recruiting participants for this study, which was initially uploaded on May 1st 2006 and last revised on July 7th 2022."

Answered by AI

What is the current participant count for this clinical investigation?

"Affirmative. According to the clinicaltrials.gov entry, this medical trial is still seeking participants since it was posted on May 1st 2006 and last updated on July 7th 2022. 200 individuals are needed from a single site for participation in the study."

Answered by AI

Has the Food and Drug Administration sanctioned iobenguane I 131 for medical use?

"We rate iobenguane I 131's safety at 2 on a 3-point scale. This is due to the trial being in Phase 2, where there are some data points indicating its security but none validating its efficacy."

Answered by AI

Recent research and studies

Journal of Nuclear MedicineJournal

Arsenic Trioxide as a Radiation Sensitizer for <sup>131</sup>i-metaiodobenzylguanidine Therapy: Results of a Phase II Study

Modak, Shakeel, Pat Zanzonico, Jorge A. Carrasquillo, Brian H. Kushner, Kim Kramer, Nai-Kong V. Cheung, Steven M. Larson, and Neeta Pandit-Taskar. 2016. “Arsenic Trioxide as a Radiation Sensitizer for 131i-metaiodobenzylguanidine Therapy: Results of a Phase II Study”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.115.161752.

Pediatric Blood & CancerJournal

Feasibility of Administering High-dose<sup>131</sup>i-mibg Therapy to Children with High-risk Neuroblastoma Without Lead-lined Rooms

Chu, Bae P., Christopher Horan, Ellen Basu, Lawrence Dauer, Matthew Williamson, Jorge A. Carrasquillo, Neeta Pandit-Taskar, and Shakeel Modak. 2016. “Feasibility of Administering High-dose131i-mibg Therapy to Children with High-risk Neuroblastoma Without Lead-lined Rooms”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.25892.

clinicaltrials.govStudy

Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

2006. "Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00107289.

All > Paraganglioma > Neuroblastoma