Using electric fields to treat spinal cancer spread in breast cancer patients
Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine
This study tests if wearing a portable device that uses electric fields can help breast cancer patients whose cancer has spread to the spine feel better and slow down tumor growth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, methotrexate |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05746325 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) for patients with breast cancer that has metastasized to the leptomeninges of the spine. Participants will wear a portable device that generates electric fields aimed at inhibiting tumor cell growth. The study will assess the treatment's effectiveness through various methods, including MRI imaging and patient-reported symptoms. The goal is to gather data that could lead to improved therapies for leptomeningeal metastases in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of leptomeningeal metastases from breast cancer.
Not a fit: Patients without leptomeningeal metastases or those with a life expectancy of less than six weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-invasive option for managing leptomeningeal metastases in breast cancer patients.
How similar studies have performed: While the use of tumor treating fields is a novel approach in this specific context, similar studies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Wendy J. Sherman, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.