131-I-MIBG Therapy for Refractory Neuroblastoma, Expanded Access Protocol

Status:

AVAILABLE

131-I-MIBG Therapy for Refractory Neuroblastoma, Expanded Access Protocol

Lead Sponsor:

John Maris

Conditions:

Neuroblastoma

Childhood Metastatic Pheochromocytoma

Eligibility:

All Genders

1+ years

Brief Summary

Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma cells. MIBG is combined with radioactive iodine (131 I) in the laboratory to form a radioactive compound 131 I-MIBG. Thi...

Detailed Description

131I-MIBG is experimental, but has been used in more than 100 children in the United States by itself to treat relapsed neuroblastoma. A recent study using increasing doses of 131I-MIBG in both childr...

Eligibility Criteria

Inclusion

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.

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01163383

Last Update

July 25 2025

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