AzTrials
AzTrials

Low-Grade GliomaPhase 2OVIMA-1210NCT02197637

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

A Phase 2 study testing ORAL VINORELBINE in people with Low-Grade Glioma, run by Centre Oscar Lambret at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Low-Grade Glioma
What is being tested?
ORAL VINORELBINE
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
16 sitesFrance
Study dates
May 2014to Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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:
Show all 41Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU d'Angers

    Angers, 49033

  • CHU de Bordeaux

    Bordeaux, 33076

  • CHU de Grenoble

    Grenoble, 38043

  • Centre Oscar Lambret

    Lille, 59020

  • CHU de Limoges

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital de la TIMONE

    Marseille, 13385

  • CHRU Arnaud de Villeneuve

    Montpellier, 34000

  • CHU de Nancy

    Nancy, 54500

  • Institut Curie

    Paris, 75005

  • CHU de Reims

    Reims, 51100

  • CHU de Rennes - Hôpital Sud

    Rennes, 35203

  • CHU de Rouen

    Rouen, 76031

  • Hôpital Hautepierre

    Strasbourg, 67098

  • Hôpital des Enfants

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

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.

Read the 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, medical costs and quality of life.

Being tested
ORAL VINORELBINE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORAL VINORELBINEDrug

    Also called NAVELBINE

    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.

Study groups in NCT02197637
Study groupRoleWhat they receive
ORAL VINORELBINEExperimentalOrally 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
Receives: Drug: ORAL VINORELBINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    no progressive disease according to RANO criteria

    Measured: 9 months

Secondary outcomes (11)

  1. Response rate

    Complete, partial and minor responses according to RANO criteria

    Measured: 6 months

  2. Response rate

    Complete, partial and minor responses according to RANO criteria

    Measured: 12 months

  3. Progression Free Survival PFS

    No progressive disease according to RANO criteria

    Measured: 36 months

  4. Overall Survival OS

    Death incidence

    Measured: 36 months

  5. Growth Modulation Index GMI

    GMI defined as PFS2/ PSF1 ratio (PFS2 = PFS since the beginning of study treatment ; PFS1 = PFS observed in previous line of treatment)

    Measured: 36 months

  6. Adverse events

    According to NCI-CTC AE scale v4.0

    Measured: 12 months

  7. Modifications of tumor aspects in diffusion and perfusion MRI

    Cerebral and/or spinal MRI (morphological and functional) with 2 dimensional assessment of target lesions.

    Measured: At each tumor assessment, after 3, 6, 9 and 12 cycles of treatment, at the end of study, then every 4 months during the first year post therapy, then every 6 months for 3 years, if no prior progressive disease

  8. Constitutional polymorphisms of cyp3A5, ABCB1

    Single nucleotide polymorphisms (SNPs) will be analyzed by real time PCR and correlated with efficacy and toxicity of vinorelbine

    Measured: Before the start of treatment

  9. Pharmacokinetic

    Plasmatic concentrations measured by LC-MS/MS (liquid chromatography tandem mass spectrometry) ; Area under the curve (AUC), maximal concentration (Cmax), time to Cmax (Tmax).

    Measured: cycles 1 and 2, prior to the initial dose, 30 min, 1, 1.5, 2, 3, 6, 8, 10 and 26 hours post-dose

  10. Medical costs

    Costs of medical care including : hospitalisations, emergency admissions, nursing care at home, medical consultations, diet support...

    Measured: during all the study (up to 1 year)

  11. Health Utilities Index (HUI)

    Health Utilities Index (HUI)

    Measured: Before the treatment, then at day 1 of 1st cycle, after the 3th, 6th, 9th and the 12th cycles of study treatment, and at the end of study (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2019
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02197637
Sponsor's protocol ID
OVIMA-1210
Other IDs
2013-001625-12, PHRC 12- 194
Acronym
OVIMA-1210
Status last verified
Nov 2020
First submitted
9 May 2014
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORAL VINORELBINE in people with Low-Grade Glioma, run by Centre Oscar Lambret at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02197637.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in