The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days. Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
CHU, Hôpital d'Enfants de la Timone
Marseille, France
Institut Curie
Paris, France
General health evaluation
NCI-CTC scale, version 3, appendix 6
Time frame: From day 21 post-dose
Changes in neurological condition related to the tumor (motor deficit, sensory deficit, cranial nerves pairs defect, cerebellar syndrome, vertebrobasilar defect, pyramidal tract syndrome) assessed during clinical examination
Time frame: From day 21 post-dose
Complete blood count (platelet included)
Time frame: 2 times/week from day 0
ALAT/ASAT measurement
Time frame: From day 21 post-dose
Bilirubin test
Time frame: From day 21 post-dose
Prothrombin test
Time frame: From day 21 post-dose
Fibrin measurement
Time frame: From day 21 post-dose
Partial thromboplastin time test
Time frame: From day 21 post-dose
Creatinine blood test
Time frame: From day 21 post-dose
Analysis of the electrolyte composition of the blood
Time frame: From day 21 post-dose
Blood urea analysis
Time frame: From day 21 post-dose
Glycemia analysis
Time frame: From day 21 post-dose
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Unité d'Hémato-Oncologie, CHU, Hôpital des enfants
Toulouse, France
CHU, Hôpital d'Enfants
Vandœuvre-lès-Nancy, France
Institut Gustave-Roussy
Villejuif, France
Calcemia analysis
Time frame: From day 21 post-dose
Protidaemia analysis
Time frame: From day 21 post-dose
Normality of ECG
Time frame: From day 21 post-dose
Echocardiography with analysis of ventricular ejection and shortening fractions
Time frame: From day 21 post-dose
Measure of initial tumors with MRI
Time frame: from day 42, after each 2 treatments
Antitumoral activity (radiological criteria of SIOP protocol)
Time frame: from day 42, after each 2 treatments
Plasma measurement of free doxorubicin
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of encapsulated doxorubicin
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose
Plasma measurement of doxorubicinol
Time frame: 0, 2, 5, 11, 47, 71 hours after the first dose