Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

March 31, 2016

Study Completion Date

July 31, 2016

Conditions
Neuroblastoma
Interventions
DRUG

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)

PROCEDURE

Autologous hematopoietic stem cell transplantation

Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG

RADIATION

iobenguane I 131

444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity

RADIATION

total-body irradiation

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)

Trial Locations (3)

31059

Hôpital des Enfants, Toulouse

59020

Centre Oscar Lambret, Lille

69373

Centre Léon Bérard, Lyon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Centre Oscar Lambret

OTHER