Study on High-Dose Methotrexate for Breast Cancer with Leptomeningeal Metastasis

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02422641

Provider View

This clinical trial is exploring the use of high-dose methotrexate, a chemotherapy drug, to treat breast cancer that has spread to the membranes surrounding the brain and spinal cord, known as leptomeningeal metastasis.

Patient Parameters

Program Overview

This study focuses on treating breast cancer that has spread to the leptomeninges, the membranes covering the brain and spinal cord. High-dose methotrexate (HD-MTX) is being tested because it can cross the blood-brain barrier, potentially reaching areas that other treatments cannot. While some past studies suggest HD-MTX might help, more research is needed to confirm its effectiveness. This trial aims to see if HD-MTX can improve survival in patients with certain types of breast cancer that have spread to the leptomeninges, with or without additional brain involvement.

Description

Breast cancer that spreads to the leptomeninges is challenging to treat, and current options are limited. High-dose methotrexate (HD-MTX) is a chemotherapy drug that can penetrate the blood-brain barrier, which is a protective layer that often blocks medications from reaching the brain. This study is testing whether HD-MTX can help patients with breast cancer that has spread to the leptomeninges, potentially improving survival rates. The study will include patients with specific types of breast cancer, such as triple-negative, HER2-positive, and hormone-resistant cancers. The main goal is to see if HD-MTX can help patients live longer than 12 weeks. Participants will receive HD-MTX through an IV, and researchers will monitor their health and response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Diagnosed with invasive breast cancer that is:
    • Triple-negative (ER-negative, PR-negative, HER2-negative).
    • HER2-positive.
    • Hormone-resistant after two lines of hormonal therapy or showing rapid disease progression.
  • Confirmed leptomeningeal metastasis through imaging or spinal fluid analysis.
  • Adequate organ function, including:
    • Creatinine clearance over 70 cc/min.
    • White blood cell count over 3000 cells/mcL.
    • Neutrophil count over 1500 cells/mcL.
    • Platelet count over 100,000 cells/mcL.
    • Hematocrit over 30%.
    • Normal liver function tests.
  • Able to provide informed consent.

Exclusion Criteria

  • Allergy or adverse reaction to methotrexate.
  • Severe heart failure (Class 3 or higher).
  • Active diabetes insipidus or mucositis.
  • Recent chemotherapy or brain radiation.
  • Prior methotrexate treatment within the last year.
  • Concurrent cancer treatments.
  • Uncontrolled systemic disease.
  • Inability to undergo MRI.
  • Use of certain medications like NSAIDs or sulfonamides within a week of starting methotrexate.
  • Pregnant or breastfeeding women.
  • Significant fluid buildup in the body, such as ascites or pleural effusions.

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