Breast Cancer Clinical Trials

Find Breast Cancer Clinical Trials Near You

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-04-07
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 5
Treatments
Experimental: Treatment (TTFields, digital photos)
Patients have transducer arrays applied and digital photographs taken of placement on study. Patients wear the NovoTTF-200T portable system on study. Patients also undergo MRI and may undergo LP during screening and on study.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov