NCT05746325Recruiting
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 14 Feb 2023
- Start date
- 5 May 2023
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT05746325
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 5 May 2023 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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 with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)
Other illness
- Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
- Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
Age
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.