Prospective evaluation of high-dose (8 g/m2) systemic methotrexate in patients with breast cancer and leptomeningeal metastasis
Johns Hopkins Kimmel Cancer Center in Baltimore
The primary objective is to determine if treatment with systemic intravenous HD-MTX will result in an overall survival (OS) exceeding 12 weeks at 80% among patients with triple negative, HER2-positive, and hormone refractory metastatic breast cancer patients with LMD with and without parenchymal brain involvement.One-year survival will be defined as the proportion of patients whose time from first date of treatment to death from any cause greater than 12 months.
Enrolling patients with triple negative, HER2-positive, or hormone refractory metastatic breast cancer with LMD with or without parenchymal brain involvement.Enrolled patients will undergo treatment with HD-MTX as per current standard practice on an every 2 week schedule until disease progression, death from any cause, or intolerance.ECOG 0-1WBC greater than 3000/mm3ANC greater than 1500/mm3PLT greater than 100,000 cells/cc3Exclusion:NYHA Heart Failure Class greater than 3, active mucositis, chemotherapy or stereotactic radiotherapy within the last 2 weeks, whole brain radiotherapy within the last 6 months, prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate), concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or Her-2 directed therapy directed at management of breast cancer (existing Her-2 therapy can be continued as recently recommended in the National Consensus Guidelines (26), severe or uncontrolled systemic disease or other concurrent medical condition
Day 1-5 hospitalization per standard protocol.Day 1- hydrationDay 1-3 anti-emeticsDay 1-5 Methotrexate Administration
12/14/2019 05:03 AM