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Tumor Treating Fields for Spinal Leptomeningeal Metastases in Breast or Lung Cancer

This study is looking at how safe and practical it is to use Tumor Treating Fields (TTFs) for breast or lung cancer that has spread to the lining of the brain and spinal cord (leptomeningeal metastases) in the spine. You would wear a portable device called NovoTTF-200T, which creates electric fields to help stop cancer cells from growing. To join, you must be at least 18 years old and have a confirmed diagnosis of breast or lung cancer with leptomeningeal metastases in your spine. The study aims to see if the device can be worn successfully and to look for early signs that it might be helping. The study plans to enroll 5 participants.

Study design
This is an interventional study, meaning you will receive a specific treatment. It plans to enroll 5 participants.
What's involved
You would have transducer arrays applied to your body and digital photographs taken. You would wear the NovoTTF-200T device, and undergo MRI scans and possibly lumbar punctures (spinal taps) to collect cerebrospinal fluid (CSF).
Compensation
Not stated in the trial record.
Follow-up
After the study treatment, you would be followed up every 3 or 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05746325

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

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~5 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Digital PhotographyLumbar PunctureMagnetic Resonance ImagingMedical Device Usage and EvaluationBiospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of significant toxicity of tumor treating fields (TTFs)
Measured over Up to 3 years
+1 more outcome measured

Conditions

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

Explore related trials

Breast CarcinomaLung CarcinomaMetastatic Malignant Neoplasm in the Leptomeninges

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Wendy J. Sherman, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Incidence of significant toxicity of tumor treating fields (TTFs)Up to 3 years

    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.

  • Feasibility of TTFs - completion of at least 28 days of TTF therapyUp to 28 days

    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.