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Iodine I 131 Metaiodobenzylguanidine for Neuroblastoma or Pheochromocytoma

This study is testing the safety and effectiveness of a drug called iodine I 131 metaiodobenzylguanidine (also known as 131I-MIBG) in patients with certain types of cancer. These include neuroblastoma (a cancer that forms in nerve tissue), malignant pheochromocytoma (a rare tumor of the adrenal gland), or malignant paraganglioma (a rare tumor that forms near the adrenal glands or in other parts of the body). You may be able to join if you are at least 1 year old and your cancer has come back, gotten worse, or hasn't responded to standard treatments. The researchers want to see if this treatment can shrink or get rid of the cancer, with results measured over two years. The current status of this study is unclear, and it plans to enroll up to 200 patients.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll up to 200 participants.
What's involved
Participants will receive a single dose of iodine I 131 metaiodobenzylguanidine intravenously. Radiation measurements will be taken to see if a second dose can be given safely.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which measures the treatment's response, is assessed at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00107289

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

Recruiting
PHASE2Ages 1+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~200 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:iobenguane I 131

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response (complete or partial)
Measured over 2 years

Conditions

Neuroblastoma
Pheochromocytoma

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NCT00107289

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ellen Basu, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Ellen Basu, MD, PhD
212-639-5204
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Eligibility criteria

Inclusion

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.
Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol
Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
Age \>1 year
Determination that radiation safety restrictions during therapy period can be implemented.
Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
Minimum life expectancy of eight weeks
Signed informed consent indicating awareness of the investigational nature of this program.
Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma
Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol
Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy.
Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period
Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg.
Minimum life expectancy of eight weeks.
Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion

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.
Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
Inability or unwillingness to comply with radiation safety procedures or protocol requirements.

What this trial measures

  • Response (complete or partial)2 years