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

Recruiting now · Not applicable

Conditions studied: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT05746325

Run by

Mayo Clinic

People needed

5

Starts

2023-04-07

Expected to finish

2027-03-01

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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)
• Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
• 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 known to be allergic to the hydrophilic gel utilized for transducer attachment
• Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)

Where it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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