Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail
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.
Detailed description
Primary Objective: \- To assess if treatment with systemic intravenous high-dose methotrexate (HD-MTX) will result in an overall survival (OS) exceeding 12 weeks at 80% among patients with triple negative, HER2-positive, and hormone refractory metastatic breast cancer patients with leptomeningeal metastasis (LMD) with and without parenchymal brain involvement. Secondary and Exploratory Objectives * To describe the one-year survival in patients with LMD from metastatic breast cancer treated with HD-MTX. * To describe the overall progression free survival (PFS) in patients with LMD from metastatic breast cancer treated with HD-MTX. * To describe the tolerability of HD-MTX in patients with LMD from metastatic breast cancer. * To describe the cost of HD-MTX treatment in patients with LMD from metastatic breast cancer. * To investigate cytologic sterilization following HD-MTX in patients with LMD from metastatic breast cancer.
Arms & 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.
Outcome measures
Primary
Overall Survival (at 12 weeks)
The primary endpoint is survival at 12 weeks from first date of treatment. For the primary analysis, this will be dichotomized according to whether the patient achieves an OS greater than 12 weeks (i.e. survival rate). This cutoff has been selected based on reported OS data in historical controls.
Time frame: 12 weeks
Secondary
One year survival
Time frame: 1 year
Progression Free Survival
Time frame: From date of first treatment to the time of systemic or neurologic progression of disease whichever occurs first, assessed up to 2 years
Tolerability of Treatment - Number of Grade 3 or Higher Adverse Events
Time frame: Up to 2 years
Number of Treatment Delays
Time frame: Up to 2 years
Number of Dose Reductions
Time frame: Up to 2 years
Eligibility criteria
Study locations (3)
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Siteman Cancer Center- Washington University School of Medicine in St. Louis
St Louis, Missouri, 63130
Comprehensive Cancer Center at Wake Forest University (CCCWFU)
Winston-Salem, North Carolina, 27157