Clinical trial · Interventional
131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
NCT00293319CI-TRIAL-00015409completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells. PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim | Biological | Filgrastim | ALIAS |
| iobenguane I 131 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
- measure
- Acute and late toxicities
Secondary outcomes (1)
- measure
- Disease and symptom responses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Original diagnosis of neuroblastoma based on 1 of the following criteria: * Histopathology * Elevated urine catecholamines with typical tumor cells in the bone marrow * Refractory or relapsed disease, meeting 1 of the following criteria: * Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery) * Evidence of disease progression (i.e., any new lesion or an increase in size of \> 25% of a pre-existing lesion) at any time * Evaluable disease by MIBG scan within 6 weeks of study entry PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * Bilirubin \< 2 times normal * AST/ALT ≤ 10 times normal * Creatinine ≤ 2 mg/dL * Absolute neutrophil count\* ≥ 750/mm\^3 (transfusion independent) * Platelet count\* ≥ 50,000/mm\^3 (20,000/mm\^3 if stem cells are available and platelet transfusion independent) * Hemoglobin\* ≥ 10 g/dL (transfusion allowed) * No dyspnea at rest * No exercise intolerance * No oxygen requirement * No clinically significant cardiac dysfunction * No disease of any major organ system that would preclude study compliance * No active infection that meets grade 3 or 4 toxicity criteria NOTE: \*Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * At least 2 weeks since prior antitumor therapy * At least 3 months since prior radiotherapy to any of the following fields: * Craniospinal * Total abdominal * Whole lung * Total body * At least 1 day since prior cytokine therapy (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin-6, or epoetin alfa) * Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available * No concurrent hemodialysis
References
Publications (1)
- RESULTMatthay KK, Yanik G, Messina J, Quach A, Huberty J, Cheng SC, Veatch J, Goldsby R, Brophy P, Kersun LS, Hawkins RA, Maris JM. Phase II study on the effect of disease sites, age, and prior therapy on response to iodine-131-metaiodobenzylguanidine therapy in refractory neuroblastoma. J Clin Oncol. 2007 Mar 20;25(9):1054-60. doi: 10.1200/JCO.2006.09.3484. PMID 17369569