Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Management of leptomeningeal disease (LMD) in patients with metastatic breast cancer is an
area of unmet clinical need. High-dose methotrexate (HD-MTX) is known to have activity
against breast cancer and in contrast to other systemic chemotherapeutics, it penetrates the
blood brain barrier, targets areas of poor cerebrospinal fluid flow, may penetrate bulky
leptomeningeal disease, and provide treatment to systemic disease burden. While two
retrospective studies have suggested activity of HD-MTX in LMD in patients with breast
cancer, no prospective data are available to inform its inclusion in treatment regimens.
Thus, while HD-MTX is included in the NCCN Guidelines for LMD and while it is used to varying
degrees in cancer centers across the nation, this is more representative of the lack of
available therapies for LMD as opposed to strong evidence-based data. This phase II,
prospective study will evaluate systemic, intravenous HD-MTX in breast cancer patients with
leptomeningeal metastasis with or without brain parenchymal metastasis.
Phase:
Phase 2
Details
Lead Sponsor:
Wake Forest University Health Sciences
Collaborators:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins