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

Launched by MAYO CLINIC · Feb 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method called Tumor Treating Fields (TTF) to help patients with breast cancer that has spread to the spinal area, specifically in the protective layers around the brain and spinal cord. The TTF therapy involves wearing a portable device that creates electric fields aimed at stopping the growth of cancer cells. This trial is important as it aims to find out how safe and effective this treatment is for patients facing this challenging condition.

To participate, patients need to be at least 18 years old and have a confirmed diagnosis of breast cancer that has spread to the spinal area. They should also have a life expectancy of at least six weeks and be able to wear the TTF device for at least 18 hours a day. Participants will be closely monitored throughout the study to assess how well the treatment works and to ensure their safety. This trial is currently recruiting participants, and those interested should speak with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>= 18
• • Prior tissue diagnosis of breast 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)