This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast or lung 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.
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
Must not be receiving concurrent high-dose methotrexate (>= 3 g/m²), high dose thiotepa, or high-dose cytarabine (>= 3 g/m²). 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)
Single group
Digital Photography
Other interventionDigital photographs taken of array placement
Lumbar Puncture
Procedure/SurgeryUndergo LP
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Medical Device Usage and Evaluation
DeviceTransducer arrays applied and wear NovoTTF-200T
Biospecimen Collection
Procedure/SurgeryUndergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously
Incidence of significant toxicity of tumor treating fields (TTFs)
Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Feasibility of TTFs - completion of at least 28 days of TTF therapy
Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.
Preliminary signals of activity - CSF cytologic response
Descriptive analyses will be performed to assess preliminary signals of activity. CSF cytologic response will be assessed for patients who had positive CSF cytology at baseline.
Preliminary signals of activity - MRI radiographic response
Descriptive analyses will be performed. Assessed by MRI radiographic response within the TTF field
Preliminary signals of activity - time to CSF cytologic repsonse
Descriptive analyses will be performed. Assessed by time to CSF cytologic response (patients with positive baseline CSF cytology only), defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations).
Preliminary signals of activity - duration of CSF cytologic response
Descriptive analyses will be performed. Assessed by time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
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