Actively Recruiting
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Led by Wake Forest University Health Sciences · Updated on 2026-03-23
16
Participants Needed
3
Research Sites
634 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age over 18 years (male and female)
- Eastern Cooperative Group (ECOG) Performance Scale 0-1
- Histologically or cytologically confirmed invasive breast cancer of triple negative, HER2-positive, or hormone refractory subtype
- Cytologic or clear radiographic confirmation of leptomeningeal metastasis with or without brain metastasis
- Adequate organ function including creatinine clearance >70 cc/min, white blood cell count >3000 cells/mcL, absolute neutrophil count >1500 cells/mcL, platelet count >100,000 cells/mcL, hematocrit >30%, and liver enzyme levels within specified limits
- Able to provide confirmed consent
You will not qualify if you...
- Prior allergy or adverse reaction to methotrexate
- New York Heart Association Heart Failure Class greater than 3
- Active diabetes insipidus or active mucositis
- Chemotherapy or stereotactic radiotherapy within the last 2 weeks
- Partial brain radiotherapy involving less than 40% of brain volume within the last 2 weeks
- Whole brain radiotherapy within the last 6 months or partial brain radiotherapy exceeding 40% of brain volume 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 anti-HER2 therapy for breast cancer management (continuation of existing anti-HER2 therapy allowed)
- Uncontrolled or progressive systemic disease or other conditions making HD-MTX unsuitable
- Contraindication to MRI
- Use of salicylates, NSAIDs, or sulfonamide medications within one week before starting methotrexate
- Pregnant or breastfeeding women
- Significant fluid collections such as ascites grade >2, pleural effusions >200 mL or symptomatic pleural effusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
Siteman Cancer Center- Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63130
Active, Not Recruiting
3
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
S
Strowd Roy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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