Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
OVIMA-1210
3 other identifiers
interventional
39
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2014
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 9, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 18, 2020
November 1, 2020
5.3 years
May 9, 2014
November 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival
no progressive disease according to RANO criteria
9 months
Secondary Outcomes (11)
Response rate
6 months
Response rate
12 months
Progression Free Survival PFS
36 months
Overall Survival OS
36 months
Growth Modulation Index GMI
36 months
- +6 more secondary outcomes
Study Arms (1)
ORAL VINORELBINE
EXPERIMENTALOrally 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 ;
- +12 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- National Cancer Institute, Francecollaborator
- Pierre Fabre Laboratoriescollaborator
Study Sites (16)
CHU d'Angers
Angers, 49033, France
CHU de Bordeaux
Bordeaux, 33076, France
CHU de Grenoble
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
CHU de Limoges
Limoges, 87042, France
Centre Léon Bérard
Lyon, 69373, France
Hôpital de la TIMONE
Marseille, 13385, France
CHRU Arnaud de Villeneuve
Montpellier, 34000, France
CHU de Nancy
Nancy, 54500, France
Institut Curie
Paris, 75005, France
CHU de Reims
Reims, 51100, France
CHU de Rennes - Hôpital Sud
Rennes, 35203, France
CHU de Rouen
Rouen, 76031, France
Hôpital Hautepierre
Strasbourg, 67098, France
Hôpital des Enfants
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre LEBLOND, MD, PhD
Centre Oscar Lambret, Lille, France
- PRINCIPAL INVESTIGATOR
Nicolas ANDRE, MD, PhD
Hôpital La Timone, Marseille, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2014
First Posted
July 23, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2019
Study Completion
October 1, 2020
Last Updated
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share