Radioactive 'Smart Bomb' targets tough childhood cancer
NCT ID NCT01163383
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This expanded access program provides 131 I-MIBG therapy for children and young adults with refractory or relapsed neuroblastoma, a cancer that hasn't responded to standard treatments. The therapy uses a radioactive compound that is taken up by cancer cells, delivering radiation directly to kill them. Patients receive intravenous doses every 4-8 weeks, and the program also collects data on how well it works and any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 131 I-Metaiodobenzylguanidine (131 I-MIBG)
- What this could lead to
- If successful, this therapy could offer a treatment option for children with neuroblastoma that hasn't responded to standard treatments, potentially shrinking tumors and improving outcomes.
- What could go wrong
- This is an expanded access protocol, not a formal trial, so data is limited. Response rates vary, 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.
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Refractory or relapsed neuroblastoma * Age greater than 1 year. * Performance Level: Patients must have a Karnofsky or Lansky performance status of equal to or greater than 50 percent * Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any time. Disease evaluable by MIBG scan must be present within 8 weeks of study entry and subsequent to any intervening therapy. The principal or co-investigator can waive the requirement for intervening therapy if in their judgment this would pose undue risk and would not affect ability to judge treatment effectiveness. * Stem cells: Patients must have a hematopoietic stem cell product available for re-infusion after MIBG treatment at doses of \>/= 12 mCi/kg. The recommended minimum quantity for peripheral blood stem cells based on documentation from the time of collection is 1.0 x 10\^6 CD34+ cells/kg. The minimum dose for bone marrow is 1.0 x 10\^8 mononuclear cells/kg. If no stem cells are available, the dose of 131I-MIBG should be ≤ 12 mCi/kg. * Prior Therapy: Patients may enter this study with or without re-induction therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy. Subjects cannot be receiving chemotherapy, cytokine therapy or other investigational agents, and must have fully recovered from the toxic effects of any prior therapy. No investigational agents are allowed in this time frame, but FDA-approved drugs for other indications that are not cytotoxic are allowed to be used off label if this is considered in the best interest of the patient by the investigator. No concomitant cytotoxic therapy is permitted with the exception of vorinostat. * Liver function: Bilirubin ≤2x upper limit of normal; AST/ALT ≤10x upper limit of normal * Kidney function: Creatinine ≤3x upper limit of normal * Signed informed consent: The patient and/or the patient's legally authorized guardian must provide written informed consent to participate in this expanded access protocol. Exclusion criteria * Patients with disease of any major organ system that would compromise their ability to withstand therapy, as deemed by the principal investigator or treating sub-investigator. * Because of the teratogenic potential of the study medications, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus. * Patients who are on hemodialysis * Patients with uncontrolled infections * Exceptions to the above eligibility criteria may be allowed if approved by the principal investigator as long as exception does not compromise the safety of the subject and the exception is clearly documented. Each protocol exception must be reviewed by the Institutional Review Board before therapy is initiated.
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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. 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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The Children's Hospital of Philadelphia
AVAILABLEPhiladelphia, Pennsylvania, 19104, United States
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