Radioactive therapy takes aim at resistant childhood cancer
NCT ID NCT00107289
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests a radioactive drug called I-MIBG in people with resistant neuroblastoma or related tumors (pheochromocytoma and paraganglioma). The drug is designed to deliver radiation directly to cancer cells. Researchers want to see if it can shrink tumors and how safe it is. The trial is open to patients whose cancer has not responded to standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radioactive iodine (I-131 MIBG)
- What this could lead to
- If it works, this could offer a treatment option for patients with resistant neuroblastoma or related tumors that have not responded to standard therapy.
- What could go wrong
- This is a phase 2 trial, so it is still early. The treatment may not shrink tumors in all patients, and there are risks from radiation exposure, including potential damage to healthy tissues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2006
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria for NB: * 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. Inclusion criteria for malignant CCT: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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- Can a shorter chemo combo tame High-Risk neuroblastoma?