Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
NCT ID: NCT02197637
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2014-05-31
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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 If on D8 and D15, the administration conditions are not met, the administration is canceled and not delayed.
Interventions
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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 If on D8 and D15, the administration conditions are not met, the administration is canceled and not delayed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
17 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Pierre Fabre Laboratories
INDUSTRY
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Pierre LEBLOND, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret, Lille, France
Nicolas ANDRE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital La Timone, Marseille, France
Locations
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CHU d'Angers
Angers, , France
CHU de Bordeaux
Bordeaux, , France
CHU de Grenoble
Grenoble, , France
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
CHU de Reims
Reims, , France
CHU de Rennes - Hôpital Sud
Rennes, , France
CHU de Rouen
Rouen, , France
Hôpital Hautepierre
Strasbourg, , France
Hôpital des Enfants
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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2013-001625-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC 12- 194
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
OVIMA-1210
Identifier Type: -
Identifier Source: org_study_id