Clinical trial · Interventional
131I-MIBG With Myeloablative Chemotherapy and Autologous Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
NCT00798148CI-TRIAL-00007048unknownPhase 1 / Phase 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)
This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MIBG
- interventionNames
- Drug: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation
Primary outcomes (1)
- measure
- Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
- timeFrame
- one-years post stem cell transplantation
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- one-year after stem cell tranplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites * High risk according COG (Children Oncology Group)OR Relapse OR Refractory * As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan * Glomerular filtration rate or creatinine clearance \> 60 ml/min * No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection * No active infection Exclusion Criteria: * Impaired renal function * No avid I131-MIBG lesion * Active infection
References
Publications (0)
Data not yet available
No reference posted for this study.