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Title:
Prospective evaluation of high-dose (8 g/m2) systemic methotrexate in patients with breast cancer and leptomeningeal metastasis
Protocol Number:
J14166
Phase:
Phase II
Physician:
Matthias Holdhoff
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
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.
Eligibility:
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
Treatment:
Day 1-5 hospitalization per standard protocol.Day 1- hydrationDay 1-3 anti-emeticsDay 1-5 Methotrexate Administration
Population:
Adult
Last Update
12/14/2019 05:03 AM