Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma (OVIMA-1210)

This is an interventional treatment trial for Low-Grade Glioma Read More

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
• 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 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
• 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