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

Korábbi kezelés

• 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
• 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 with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)

Más betegség

• Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
• Patients known to be allergic to the hydrophilic gel utilized for transducer attachment

Életkor

• 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)

• 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)
• 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) >= 30 mL/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