Trials / Completed
CompletedNCT02197637
Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Centre Oscar Lambret · Academic / Other
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2019-08-01
- Completion
- 2020-10-01
- First posted
- 2014-07-23
- Last updated
- 2020-11-18
Locations
16 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02197637. Inclusion in this directory is not an endorsement.