RecruitingPhase 2NCT02422641

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

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail


Sponsor

Wake Forest University Health Sciences

Enrollment

16 participants

Start Date

May 1, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether high-dose methotrexate given as an intravenous infusion (into the bloodstream) can treat breast cancer that has spread to the lining of the brain and spinal cord — a serious complication called leptomeningeal metastasis. **You may be eligible if...** - You are over 18 years old and in generally good physical condition - You have been diagnosed with invasive breast cancer that is triple-negative (ER-, PR-, HER2-), HER2-positive, or hormone-receptor-positive but no longer responding to hormone therapy - Your cancer has been confirmed to have spread to the lining of the brain or spinal cord - Your blood counts, kidney, and liver function are within acceptable ranges **You may NOT be eligible if...** - You have had a previous allergic reaction to methotrexate - You have severe heart failure or active mouth sores - You received chemotherapy or brain radiation within the past 2 weeks (or whole-brain radiation in the past 6 months) - You had systemic methotrexate treatment within the past year - You are currently receiving other cancer treatments - You are pregnant or breastfeeding - You take aspirin, anti-inflammatory pain medications (NSAIDs), or certain antibiotics within one week of starting treatment - You have significant fluid buildup in your abdomen or around your lungs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh-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.


Locations(3)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

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

St Louis, Missouri, United States

Comprehensive Cancer Center at Wake Forest University (CCCWFU)

Winston-Salem, North Carolina, United States

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NCT02422641


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