Vinorelbine for Children With Progressive or Recurrent Low-grade Gliomas

Status: Recruiting
Phase:
Diagnosis: Pediatric Oncology, Pediatric Brain Tumor
NCT ID: NCT01497860 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-148

 

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.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Susan Chi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

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
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