Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
Mayo Clinic
Summary
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.
Description
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, ce…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) * 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 * A…
Interventions
- OtherDigital Photography
Digital photographs taken of array placement
- ProcedureLumbar Puncture
Undergo LP
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- DeviceMedical Device Usage and Evaluation
Transducer arrays applied and wear NovoTTF-200T
- ProcedureBiospecimen Collection
Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously
Location
- Mayo Clinic in FloridaJacksonville, Florida