Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

November 30, 2018

Study Completion Date

January 31, 2022

Conditions
Glioma
Interventions
DRUG

Fluvastatine

"Escalation dose : Level 1: 2mg/kg/day. Level 2: 4mg/kg/day. Level 3: 6mg/kg/day. Level 4: 8mg/kg/day.~Per os from D1 to D14 of each 28 day cycle.~Number of Cycles: until progression or unacceptable toxicity develops."

DRUG

Celebrex

"Dose levels : 100 mg twice a day (\< 20 kg), 200 mg twice a day (20-50 kg), 400 mg twice a day (\> 50 kg)~Per os from D1 to D28 of each 28 day cycle.~Number of Cycles: until progression or unacceptable toxicity develops."

Trial Locations (8)

13385

Hôpital pour enfants La Timone, Marseille

31026

Centre Hospitalier de Purpan - Hôpital des Enfants, Toulouse

49933

CHU Angers, Angers

54511

Centre Hospitalier de Nancy, Vandœuvre-lès-Nancy

59020

Centre Oscar Lambret, Lille

67098

Centre Hospitalier de Strasbourg, Strasbourg

69373

Centre Léon Bérard, Lyon

75005

Institut Curie, Paris

All Listed Sponsors
collaborator

Anticancer Fund, Belgium

OTHER

lead

Centre Oscar Lambret

OTHER

NCT02115074 - Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas | Biotech Hunter | Biotech Hunter