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

Sponsor
Centre Oscar Lambret
Study ID
NCT02197637
Phase
PHASE2
Status
Completed

Conditions

  • Low-Grade Glioma

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • ORAL VINORELBINE — DRUG
    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 Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Nov 2020
Primary completion
Aug 31, 2019
Completion
Oct 31, 2020

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Progression free survival [ Time Frame: 9 months ]

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