Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma

Centre Oscar Lambret16 sites in 1 country39 target enrollmentMay 2014

ConditionsLow-Grade Glioma

InterventionsORAL VINORELBINE

DrugsORAL VINORELBINE

Overview

Phase: Phase 2
Intervention: ORAL VINORELBINE
Conditions: Low-Grade Glioma
Sponsor: Centre Oscar Lambret
Enrollment: 39
Locations: 16
Primary Endpoint: Progression free survival
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

October 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Oscar Lambret

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•TUMOR CHARACTERISTICS:
•Histologically confirmed recurrent or progressive primary Low-Grade Glioma (LGG) defined as follow (WHO classification 2007): optic pathway glioma (OPG), pilocytic astrocytoma (PA), fibrillary or diffuse astrocytoma (DA), oligodendroglioma (OG) or oligoastrocytoma (OA)
•Patients with OPG do not require biopsy confirmation of disease, if clinical and radiological findings as well as ophthalmological examination are unequivocal
•Low-Grade Glioma involving the brainstem can be included in case of histological confirmation
•Tumor has to be considered as non totally resectable
•PATIENT CHARACTERISTICS:
•Age 6-18 years old
•Lansky or Karnofsky status more than 50 %
•Measurable disease on cerebral and/or spinal MRI, with at least 1 lesion diameter superior to 1 cm
•Patients with metastatic disease are eligible, but at least 1 lesion must be measurable as previously defined

Exclusion Criteria

•Inclusion criteria failure
•Prior treatment with intravenous or oral vinorelbine
•Known hypersensibility to other vinca-alkaloïdes
•Digestive pathology affecting absorption in a important way
•Prior surgical resection of stomach or the small intestine
•Severe hepatic failure independent from tumoral disease
•Fructose intolerance
•Leptomeningeal relapse without any available measurable disease on MRI (for example, leptomeningeal relapse with totally resected primary lesion)
•Uncontrolled active infection within 2 weeks
•Pregnancy or breast feeding woman

Arms & Interventions

ORAL VINORELBINE

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

Intervention: ORAL VINORELBINE

Outcomes

Primary Outcomes

Progression free survival

Time Frame: 9 months

no progressive disease according to RANO criteria

Secondary Outcomes

Response rate(12 months)
Progression Free Survival PFS(36 months)
Overall Survival OS(36 months)
Adverse events(12 months)
Growth Modulation Index GMI(36 months)
Modifications of tumor aspects in diffusion and perfusion MRI(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)
Constitutional polymorphisms of cyp3A5, ABCB1(Before the start of treatment)
Pharmacokinetic(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(during all the study (up to 1 year))
Health Utilities Index (HUI)(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))