Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients with Breast or Lung Cancer

Inclusion Criteria

• Age >= 18
• Prior tissue diagnosis of breast cancer or lung cancer
• Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C); or, if CSF negative, presence of clinical symptoms or signs compatible with LM, and recent (< 1 year) or active systemic cancer
• Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
• Life expectancy of at least 6 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
• Recovery from any neurotoxic effects of prior therapy
• Platelet count greater than 25 x 10^9/L
• Absolute neutrophil count (ANC) greater than 0.5 x 10^9/L
• Patients must have adequate liver function, total bilirubin < 2.5 mg/dL, 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] >= 30mL/min/body surface area [BSA])
• Patients or legal medical representative must provide written informed consent
• Patients must have suitable body habitus for placement of transducer arrays
• Patients 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 assessments
• Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF
• Patient willing to start a study treatment with TTF =< 14 days from registration

Exclusion 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 permitted * Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF * Must be at least 1 week from cessation of any prior intrathecal chemotherapy
• Women 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 toxicity
• Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
• Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)