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

Trial Title: Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients with Breast Cancer

NCT ID: NCT05746325

Condition: Anatomic Stage IV Breast Cancer AJCC V8
Metastatic Breast Carcinoma
Metastatic Malignant Neoplasm in the Leptomeninges

Conditions: Official terms:
Carcinoma
Breast Neoplasms
Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Digital Photography
Description: Digital photographs taken of array placement
Arm group label: Treatment (TTFields, digital photos)

Intervention type: Procedure
Intervention name: Lumbar Puncture
Description: Undergo LP
Arm group label: Treatment (TTFields, digital photos)

Other name: LP

Other name: Spinal Tap

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Treatment (TTFields, digital photos)

Other name: Magnetic Resonance

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

Intervention type: Device
Intervention name: Medical Device Usage and Evaluation
Description: Transducer arrays applied and wear NovoTTF-200T
Arm group label: Treatment (TTFields, digital photos)

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 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.

Detailed description: PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of TTFields in treatment of the spinal component of leptomeningeal metastases. SECONDARY OBJECTIVE: I. To document any preliminary signals of activity, as measured by radiographic and clinical response, or durable stability of objective neurologic examination, utilizing Leptomeningeal Assessment in Neuro-Oncology (LANO) criteria, magnetic resonance imaging (MRI) imaging, cerebrospinal fluid (CSF) cytologic examination, and patient-reported symptom assessment (M. D. Anderson Symptom Inventory [MDASI]-spine module). OUTLINE: 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 lumbar puncture (LP) during screening and on study.

Criteria for 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Florida

Address:
City: Jacksonville
Zip: 32224-9980
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Contact backup:
Last name: Kurt A. Jaeckle, M.D.

Start date: April 7, 2023

Completion date: March 1, 2027

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05746325
https://www.mayo.edu/research/clinical-trials