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

NCT05746325 | Recruiting DMC FDA Device

• 2 other identifiers: MC21030321-005732
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Incidence of significant toxicity of tumor treating fields (TTFs)

  Will be measured by incidence of grade 3 or greater non-hematologic adverse events that persist despite temporary interruption of treatment and maximal medical management (i.e., grade 3 or greater non-hematologic toxicities that are not responsive to cessation of treatment and administration of supportive care). Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  Up to 3 years

• Feasibility of TTFs - completion of at least 28 days of TTF therapy

  Assessed by the number of patients who are unable to complete at least 28 days of TTF therapy (a composite average for the 28 days of at least 50% of array 'on' time) due to unacceptable adverse events. Treatment with TTF will be considered feasible if the stopping rule is not reached, as defined per protocol.

  Up to 28 days

Secondary Outcomes (6)

• Preliminary signals of activity - CSF cytologic response

  Up to 3 years

• Preliminary signals of activity - MRI radiographic response

  Up to 3 years

• Preliminary signals of activity - time to CSF cytologic repsonse

  Up to 3 years

• Preliminary signals of activity - duration of CSF cytologic response

  Up to 3 years

• Preliminary signals of activity - neurologic progression-free survival

  Up to 3 years

Study Arms (1)

Treatment (TTFields, digital photos)

EXPERIMENTAL

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.

Other: Digital Photography; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Device: Medical Device Usage and Evaluation; Procedure: Biospecimen Collection

Interventions

Digital Photography OTHER

Digital photographs taken of array placement

Treatment (TTFields, digital photos)

Lumbar Puncture PROCEDURE

Undergo LP

Also known as: LP, Spinal Tap

Treatment (TTFields, digital photos)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Treatment (TTFields, digital photos)

Medical Device Usage and Evaluation DEVICE

Transducer arrays applied and wear NovoTTF-200T

Treatment (TTFields, digital photos)

Biospecimen Collection PROCEDURE

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

Also known as: Biological Sample Collection, Specimen Collection

Treatment (TTFields, digital photos)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Meningeal Carcinomatosis; Lung Neoplasms

Interventions

Spinal Puncture; Magnetic Resonance Spectroscopy; Physical Examination; Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Wendy J. Sherman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 27, 2023
• Study Start: April 7, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)