The purpose of this study is to investigate whether weekly Vinorelbine treatment can shrink or slow the growth of pediatric low-grade gliomas that have either returned or are continuing to grow. Vinorelbine is a semi-synthetic vinca alkaloid that has recently generated interest in patients with pediatric low-grade glioma. It has been specifically synthesized to broaden its therapeutic spectrum and decrease the neurotoxicity associated with related agents.
Different treatments exist for children with progressive or recurrent low-grade glioma. Each has variable efficacy at slowing or reversing growth, and exploration continues into finding better-tolerated, more effective treatments. Vinorelbine has recently generated interest in stabilizing some pediatric low-grade gliomas. It has been fairly well tolerated in both adult and pediatric studies that have examined its use in other tumors. Objective: To test the efficacy of Vinorelbine in children with pediatric low-grade glioma that has returned or continues to grow. In this trial, Vinorelbine will be given intravenously once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. The patients will then be followed for 60 months. Progression free survival is the primary outcome and defined as the none of the following: greater a 20% increase in the sun of the longest diameter of the target lesion, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Children's National Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Rochester, Minnesota, United States
Progression-free Survival
IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
Time frame: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.
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