NCT05746325 · Mayo Clinic
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Jacksonville, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations