Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer

This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.

Inclusion Criteria:Age >= 18Prior tissue diagnosis of breast cancerConfirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRILife expectancy of at least 6 weeksEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3Recovery from any neurotoxic effects of prior therapyPlatelet count greater than 25,000/mm^3, and absolute neutrophil count (ANC) greater than 0.5 mm^3Patients must have adequate liver function, total bilirubin < 2.5 mg%, unless elevated total bilirubin is due to elevated indirect bilirubin from known Gilbert's disease, aspartate aminotransferase (AST) =< 3.5 times upper limits of normal; adequate renal function (calculated estimated glomerular filtration rate [eGFR] >= 30%)Patients or legal medical representative must provide written informed consentPatients must have suitable body habitus for placement of transducer arraysPatients must be willing to wear the device for at least 18 hours a day (averaged over monthly)Patients must be willing to return for the scheduled evaluations and perform the required assessmentsPatients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTFPatient willing to start a study treatment with TTF =< 14 days from registrationExclusion Criteria:Concomitant therapy:Must not be receiving concurrent high-dose methotrexate (>= 3 g/m^2), high dose thiotepa, or high-dose cytarabine (>= 3 g/m^2). Any other systemic chemotherapy, targeted treatment, hormonal or immunotherapy directed at the primary systemic malignancy is permittedMust not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTFMust be at least 1 week from cessation of any prior intrathecal chemotherapyWomen of childbearing age who are pregnant or lactating. (Male and female patients who are fertile must be willing to use an effective means of birth control to avoid pregnancy)Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)Patients receiving any other investigational agents and must not have received any other investigational agent within 14 days prior to registration. The 14-day period should be extended if the investigational agent is known to have delayed toxicityPatients known to be allergic to the hydrophilic gel utilized for transducer attachmentPatients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)