Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
- Conditions
- Neuroblastoma
- Interventions
- Procedure: Autologous hematopoietic stem cell transplantationRadiation: iobenguane I 131Radiation: total-body irradiation
- Registration Number
- NCT00960739
- Lead Sponsor
- Centre Oscar Lambret
- 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.
- Detailed Description
OBJECTIVES:
Primary
* Determine the antitumor activity of iodobenzylguanidine meta-I131 (\^131I-MIBG) and topotecan in young patients with refractory or relapsed metastatic neuroblastoma.
Secondary
* Determine the hematological and extra-hematological toxicities of this regimen.
OUTLINE: This is a multicenter study.
During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC) are collected.
Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and iodobenzylguanidine meta-\^131I IV over 2 hours on day 1. Treatment repeats every 21 days for 2 courses. Patients also undergo total-body irradiation.
On day 10 of the second course, autologous PBSC are reinfused.
After completion of study therapy, patients are followed at 6 and 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Topotecan / 131-iodine MIBG association iobenguane I 131 * 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. Topotecan / 131-iodine MIBG association Autologous hematopoietic stem cell transplantation * 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. Topotecan / 131-iodine MIBG association total-body irradiation * 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. Topotecan / 131-iodine MIBG association Topotecan hydrochloride * 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.
- Primary Outcome Measures
Name Time Method Response rate Up to 12 months
- Secondary Outcome Measures
Name Time Method Toxicity Up to 30 days after study treatment
Trial Locations
- Locations (3)
Centre Oscar Lambret
🇫🇷Lille, France
Centre Léon Bérard
🇫🇷Lyon, France
Hôpital des Enfants
🇫🇷Toulouse, France
Centre Oscar Lambret🇫🇷Lille, France