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

NCT02197637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-11-18

No results posted yet for this study

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.

Conditions

  • Low-Grade Glioma

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Pierre Fabre Laboratories

    collaborator INDUSTRY

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Pierre LEBLOND, MD, PhD · Centre Oscar Lambret, Lille, France

  • Nicolas ANDRE, MD, PhD · Hôpital La Timone, Marseille, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-08-31
Completion
2020-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197637 on ClinicalTrials.gov