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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Digital Photography
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Medical Device Usage and Evaluation
  • Biospecimen Collection

Treatment groups

5 Participants
are divided into 1 treatment group

Sponsors and collaborators