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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
Must not have
Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable
Active serious infections not controlled by antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
My neuroblastoma diagnosis is confirmed by specific tests and criteria.
Select...
My cancer has grown, come back, or didn't fully respond to standard treatments.
Select...
My neuroblastoma shows up on MIBG scans.
Select...
It's been over 2 weeks since my last biological therapy and 3 weeks since my last chemotherapy.
Select...
I have been diagnosed with a malignant pheochromocytoma or paraganglioma.
Select...
I have my stem cells stored for treatment after MIBG therapy.
Select...
I am between 1 and 21 years old and can follow safety rules during treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My major organs are mostly healthy, except I may have a serious hearing problem.
Select...
I have a serious infection that antibiotics can't control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,138 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,268 Total Patients Enrolled
24 Trials studying Pheochromocytoma
37,007 Patients Enrolled for Pheochromocytoma
Ellen Basu, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Iobenguane I 131 (Radioactive Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00107289 — Phase 2
Pheochromocytoma Research Study Groups: Radiation
Pheochromocytoma 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
~4 spots leftby May 2025
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