Clinical trial · Interventional
Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
- 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 iodobenzylguanidine meta-I131, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A stem cell transplant may be able to replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan hydrochloride. PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131 given together with topotecan hydrochloride and to see how well it works in treating young patients with refractory or relapsed metastatic 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| iobenguane I 131 | Radiation | — | UNRESOLVED |
| Topotecan hydrochloride | Drug | Topotecan | ALIAS |
| total-body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topotecan / 131-iodine MIBG association
- description
- * The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle). \* * Iobenguane I 131: 444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity up to 11,100 MBq per injection. \* * A dosimetry is performed during hospitalization. * A second dose of 131-iodine MIBG (maximum 11 100 MBq) is administered to D21 so as to obtain a total body irradiation of 4 Gy. \* * Autologous hematopoietic stem cell transplantation : Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG. * If the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled.
- interventionNames
- Drug: Topotecan hydrochloride
- Procedure: Autologous hematopoietic stem cell transplantation
- Radiation: iobenguane I 131
- Radiation: total-body irradiation
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Up to 12 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed neuroblastoma * Metastatic disease that is recurrent or refractory to induction therapy * Primary or metastatic tumor target with MIBG fixation (tumor/soft tissue) \> 2 * Autologous bone marrow or peripheral blood stem cells must be available * WHO performance status (PS) 0-1 OR Lansky PS 70-100% * Life expectancy \> 2 months * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine clearance normal for age * Not pregnant or nursing * Fertile patients must use effective contraception * No prior hypersensitivity to topotecan or its excipients * No toxicity to other organs ≥ NCI-CTCAE v3.0 grade 2 * No other debilitating disease * No HIV positivity * More than 30 days since prior external-beam radiation (6 weeks if cranio-spinal, abdominal, or pulmonary) * At least 3 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) * No other contraindicated biologic therapy that cannot be discontinued for ≥ 4 courses during MIBG therapy Exclusion criteria: * Pregnancy or breastfeeding women * HIV positive * Participation to another phase I,II or III clinical trial * Other invalidating pathology * Concomitant treatment interfering with MIBG * Hypersensibility to Topotecan
References
Publications (1)
- DERIVEDSevrin F, Kolesnikov-Gauthier H, Cougnenc O, Bogart E, Schleiermacher G, Courbon F, Gambart M, Giraudet AL, Corradini N, Badel JN, Rault E, Oudoux A, Deley MCL, Valteau-Couanet D, Defachelles AS. Phase II study of 131 I-metaiodobenzylguanidine with 5 days of topotecan for refractory or relapsed neuroblastoma: Results of the French study MIITOP. Pediatr Blood Cancer. 2023 Nov;70(11):e30615. doi: 10.1002/pbc.30615. Epub 2023 Aug 13. PMID 37574821