Status:
COMPLETED
Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
National Cancer Institute, France
Pierre Fabre Laboratories
Conditions:
Low-Grade Glioma
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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, med...
Eligibility Criteria
Inclusion
- 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
- Patients must have received at least 1 prior chemotherapy regimen containing carboplatin
- Life expectancy of at least 3 months
- Evidence of adequate organ functions, including:
- neutrophil count (ANC) ≥ 1500/mm3 ,
- platelet count ≥100 000/mm3 ;
- serum creatinine \< 1.5 x normal for age when the serum creatinine is ≥ 1.5 × the ULN, the glomerular filtration rate (either estimated or formal) must be \> 70 mL/min/1.73m2;
- total bilirubin\< 1.5 x normal for age,
- ASAT and ALAT \< 2.5 x normal for age
- Effective contraception for patients (male and female) with reproductive potential, and for a minimum of 3 months after the end of treatment
- Negative pregnancy test, if applicable
- Patients able to swallow capsules
- Patient affiliated with a health insurance system
- Written informed consent of patient and/or parents/guardians prior to the study participation.
- PRIOR OR CONCURRENT THERAPY
- Prior treatments containing vinca alkaloids like vincristine and/or vinblastine are authorized
- Patients must have fully recovered from the toxic effects of any prior therapy before entering the study. No organ toxicity superior to grade 2 according to NCI-CTCAE v4.0
- An interval of at least 2 months from prior radiotherapy, 6 weeks from nitrosourea chemotherapy, and 4 weeks from other chemotherapy regimen, is required
Exclusion
- 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
- Uncontrolled intercurrent illness or active infection
- Unsuitable for medical follow-up (geographic, social or mental reasons)
- Patients requiring long-term oxygen therapy
- Patients with ANC less than 1500/mm3
- Patients vaccinated against yellow fever
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02197637
Start Date
May 1 2014
End Date
October 1 2020
Last Update
November 18 2020
Active Locations (16)
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1
CHU d'Angers
Angers, France, 49033
2
CHU de Bordeaux
Bordeaux, France, 33076
3
CHU de Grenoble
Grenoble, France, 38043
4
Centre Oscar Lambret
Lille, France, 59020