Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
MIITOP
Phase II Study of the Association of Iodobenzylguanidine Meta-I131 (I131 MIBG) and Topotecan in the Treatment of Refractory or Relapsed Metastatic Neuroblastoma
1 other identifier
interventional
30
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2008
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 16, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 8, 2016
August 1, 2016
7.3 years
August 16, 2009
August 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate
Up to 12 months
Secondary Outcomes (1)
Toxicity
Up to 30 days after study treatment
Study Arms (1)
Topotecan / 131-iodine MIBG association
EXPERIMENTAL* 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.
Interventions
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)
Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG
444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity
the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- National Cancer Institute, Francecollaborator
- Novartis Pharmaceuticalscollaborator
Study Sites (3)
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital des Enfants
Toulouse, 31059, France
Related Publications (1)
Sevrin 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: 37574821DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Sophie Defachelles, MD
Centre Oscar Lambret
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2009
First Posted
August 18, 2009
Study Start
November 1, 2008
Primary Completion
March 1, 2016
Study Completion
July 1, 2016
Last Updated
August 8, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share