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.
PRIMARY OBJECTIVE: I. To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine. SECONDARY OBJECTIVE: I. To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory \[MDASI\]-spine module). OUTLINE: Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI during screening and on study and may undergo lumbar puncture (LP) and collection of cerebrospinal fluid (CSF) samples during screening if no CSF testing for malignancy has been done previously. After completion of study intervention, patients are followed up every 3 months or every 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Digital photographs taken of array placement
Undergo LP
Undergo MRI
Transducer arrays applied and wear NovoTTF-200T
Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGIncidence 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.
Time frame: Up to 3 years
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.
Time frame: Up to 28 days
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.
Time frame: Up to 3 years
Preliminary signals of activity - MRI radiographic response
Descriptive analyses will be performed. Assessed by MRI radiographic response within the TTF field
Time frame: Up to 3 years
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).
Time frame: Up to 3 years
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).
Time frame: Up to 3 years
Preliminary signals of activity - neurologic progression-free survival
Descriptive analyses will be performed. Assessed by neurologic progression-free survival, the time from study enrollment to documented worsening of neurological symptoms or signs of disease progression.
Time frame: Up to 3 years
Preliminary signals of activity (defined as either suspicious or positive cytology).
Descriptive analyses will be performed. Data evaluated will include: Duration of cytologic response (time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
Time frame: Up to 3 years
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