Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

PHASE2RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2027

Conditions
Metastatic Breast CancerLeptomeningeal Disease
Interventions
DRUG

High-dose Methotrexate (8 gm/m2; HD-MTX)

Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (\~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.

Trial Locations (3)

21287

RECRUITING

Sidney Kimmel Comprehensive Cancer Center, Baltimore

27157

RECRUITING

Comprehensive Cancer Center at Wake Forest University (CCCWFU), Winston-Salem

63130

ACTIVE_NOT_RECRUITING

Siteman Cancer Center- Washington University School of Medicine in St. Louis, St Louis

All Listed Sponsors
collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

lead

Wake Forest University Health Sciences

OTHER