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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT02422641
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High-dose Methotrexate (8 gm/m2; HD-MTX) — DRUG
    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.

Study Details

This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.

Key Dates

Start date
May 31, 2015
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Overall Survival (at 12 weeks) [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Siteman Cancer Center- Washington University School of Medicine in St. LouisSt LouisMissouri63130-
Comprehensive Cancer Center at Wake Forest University (CCCWFU)Winston-SalemNorth Carolina27157
Roy Strowd, MD
[email protected]

Find similar trials in Baltimore, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDSiteman Cancer Center- Washington University School of Medicine in St. Louis· St Louis, MOComprehensive Cancer Center at Wake Forest University (CCCWFU)· Winston-Salem, NC

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