vinorelbine for children with progressive or recurrent low-grade gliomas

Conditions: Low-grade Glioma

Summary: 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.

Eligibility criteria:
inclusion criteria: * age: \< 18 years * tumor: progressive or recurrent low grade glioma, who grade 1 or 2 who have failed at least one form of 'conventional' non-surgical therapy * histologic confirmation is required with the exception of optic pathway and brain stem gliomas. patients are not required to have a re-operation at time of recurrence. * patients with disseminated disease are eligible. * children with neuro-fibromatosis and optic pathway or brainstem tumors are eligible but must have definitive radiologic or clinical evidence of progression * patients must have evidence of measureable disease * performance status: karnofsky or lansky performance status of \>50% * organ function: * adequate bone marrow function (anc\>1000/mm3, platelet count of \>75,000/mm3, and hemoglobin \> 8gm/dl) prior to starting therapy. hemoglobin may be supported by transfusion * adequate liver function (sgpt/alt\<2.5 times uln and bilirubin \< 1.5 times uln) prior to starting therapy * prior therapy: * may have had treatment including surgery, chemotherapy, or radiotherapy for any number of relapses prior to enrollment * patients must have received their last fraction of radiotherapy \>12 weeks prior to starting therapy * previous vincristine or vinblastine exposure is allowable. exclusion criteria: * no other significant medical illness that in the investigators' opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy * any other cancer (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. * patients of childbearing potential must not be pregnant or breast-feeding (vinorelbine is a pregnancy category d, no data on excretion in breastmilk) * patients of childbearing or fathering potential must practice adequate contraception

Keywords: pediatric children glioma low-grade vinorelbine recurrent progressive