The purpose of this study is to determine whether oral vinorelbine is effective in the treatment of children with progressive or recurrent unresectable low grade glioma.
The aim of this study is to determine efficacy of oral vinorelbine in children with progressive or recurrent unresectable low grade glioma, in addition to safety, pharmacokinetic, pharmacogenetic, medical costs and quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Orally vinorelbine 60 mg/m2 D1, 8 and 15 Cycle of 28 days For a maximum of 12 cycles The dose of vinorelbine should be increased to 80 mg/m2 from the 2nd cycle If on D8 and D15, the administration conditions are not met, the administration is canceled and not delayed.
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
CHU de Grenoble
Grenoble, France
Progression free survival
no progressive disease according to RANO criteria
Time frame: 9 months
Response rate
Complete, partial and minor responses according to RANO criteria
Time frame: 6 months
Response rate
Complete, partial and minor responses according to RANO criteria
Time frame: 12 months
Progression Free Survival PFS
No progressive disease according to RANO criteria
Time frame: 36 months
Overall Survival OS
Death incidence
Time frame: 36 months
Growth Modulation Index GMI
GMI defined as PFS2/ PSF1 ratio (PFS2 = PFS since the beginning of study treatment ; PFS1 = PFS observed in previous line of treatment)
Time frame: 36 months
Adverse events
According to NCI-CTC AE scale v4.0
Time frame: 12 months
Modifications of tumor aspects in diffusion and perfusion MRI
Cerebral and/or spinal MRI (morphological and functional) with 2 dimensional assessment of target lesions.
Time frame: At each tumor assessment, after 3, 6, 9 and 12 cycles of treatment, at the end of study, then every 4 months during the first year post therapy, then every 6 months for 3 years, if no prior progressive disease
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Centre Oscar Lambret
Lille, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Hôpital de la TIMONE
Marseille, France
CHRU Arnaud de Villeneuve
Montpellier, France
CHU de Nancy
Nancy, France
Institut Curie
Paris, France
...and 6 more locations
Constitutional polymorphisms of cyp3A5, ABCB1
Single nucleotide polymorphisms (SNPs) will be analyzed by real time PCR and correlated with efficacy and toxicity of vinorelbine
Time frame: Before the start of treatment
Pharmacokinetic
Plasmatic concentrations measured by LC-MS/MS (liquid chromatography tandem mass spectrometry) ; Area under the curve (AUC), maximal concentration (Cmax), time to Cmax (Tmax).
Time frame: cycles 1 and 2, prior to the initial dose, 30 min, 1, 1.5, 2, 3, 6, 8, 10 and 26 hours post-dose
Medical costs
Costs of medical care including : hospitalisations, emergency admissions, nursing care at home, medical consultations, diet support...
Time frame: during all the study (up to 1 year)
Health Utilities Index (HUI)
Health Utilities Index (HUI)
Time frame: Before the treatment, then at day 1 of 1st cycle, after the 3th, 6th, 9th and the 12th cycles of study treatment, and at the end of study (up to 1 year)