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

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France; Pierre Fabre Laboratories
• Treatments: Vinblastine; Vinorelbine

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

• 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