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

NCT ID: NCT05746325

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-07
• Study Completion Date: 2027-03-01

Brief 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.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether the TTF device can be successfully placed in the three protocol-specified treatment field arrays (cervical, thoracic, and lumbar) and worn by the study patients for a meaningful period of time in the treatment of leptomeningeal metastases within the spine.

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 during screening and on study and may undergo lumbar puncture (LP) and collection of cerebrospinal fluid (CSF) samples during screening if no CSF testing for malignancy has been done previously.

After completion of study intervention, patients are followed up every 3 months or every 6 months.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Leptomeninges; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Photography

Intervention Type: OTHER

Digital photographs taken of array placement

Lumbar Puncture

Intervention Type: PROCEDURE

Undergo LP

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Medical Device Usage and Evaluation

Intervention Type: DEVICE

Transducer arrays applied and wear NovoTTF-200T

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously

Interventions

Digital Photography

Digital photographs taken of array placement

Intervention Type: OTHER

Lumbar Puncture

Undergo LP

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Medical Device Usage and Evaluation

Transducer arrays applied and wear NovoTTF-200T

Intervention Type: DEVICE

Biospecimen Collection

Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously

Intervention Type: PROCEDURE

Other Intervention Names

LP; Spinal Tap; Magnetic Resonance; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Biological Sample Collection; Specimen Collection

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy J. Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2023-00240

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-005732

Identifier Type: OTHER

Identifier Source: secondary_id

MC210303

Identifier Type: -

Identifier Source: org_study_id