Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

June 30, 2018

Study Completion Date

May 31, 2019

Conditions
RHABDOMYOSARCOMA
Interventions
DRUG

Vincristine, Irinotecan

"* D1 and D8: Vincristine 1.5 mg/m² (max 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)~* D1 to D5: Irinotecan 50 mg/m²/d, IV~ 1. cycle / 21 days"

DRUG

Vincristine, Irinotecan, Temozolomide

"* D1 to D5: Temozolomide 125 mg/m²/d, PO (the dose will be escalated to 150 mg/m²/day at cycle 2 for patients who do not experience \> grade 3 toxicity of any kind)~* D1 and D8: Vincristine 1.5 mg/m² (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)~* D1 to D5: Irinotecan 50 mg/m²/d, IV~ 1. cycle / 21 days"

Trial Locations (16)

Unknown

CHU d'Amiens Picardie Site Sud, Amiens

Hôpital des Enfants, Groupe Hospitalier Pellegrin, Bordeaux

Centre Oscar Lambret, Lille

Centre Léon Bérard, Lyon

CHU, Hôpital d'Enfants de la Timone, Marseille

Hôpital Arnaud de Villeneuve - CHU, Montpellier

CHU, Hôpital Mère enfants, Nantes

Hôpital Armand Trousseau, Paris

Institut Curie, Paris

Hôpital Jean Bernard, Poitiers

CHU Rennes - Hôpital Sud, Rennes

CHU St Etienne - Hôpital Nord, Saint-Etienne

Hôpital des enfants, Toulouse

CHRU, Tours

CHRU Hôpital d'Enfants, Vandœuvre-lès-Nancy

Institut Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

SFCE

UNKNOWN

lead

Centre Oscar Lambret

OTHER

NCT01355445 - Vincristine and Irinotecan With or Without Temozolomide in Children and Adults With Refractory/Relapsed Rhabdomyosarcoma | Biotech Hunter | Biotech Hunter