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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Photography
Lumbar Puncture
Magnetic Resonance Imaging
Medical Device Usage and Evaluation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 25,000/mm^3, and absolute neutrophil count (ANC) greater than 0.5 mm^3 Patients must have adequate liver function, total bilirubin < 2.5 mg%, 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%) 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)

Sites / Locations

  • Mayo Clinic in FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (TTFields, digital photos)

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of significant toxicity of tumor treating fields (TTFs)
Will be measured by 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 Cancer Therapy Evaluation Program Active Version Common Terminology Criteria for Adverse Events.
Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy
Will be estimated the number of patients who are unable to complete at least 30 days of TTF therapy (a composite average for the 30 days of at least 50% of array 'on' time) divided by the total number of evaluable patients.

Secondary Outcome Measures

Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP)
Descriptive analyses will be performed. Data evaluated will include: cerebral spinal fluid (CSF) cytologic response; magnetic resonance imaging radiographic response within the TTF field.
Preliminary signals of activityby Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP); and adverse events
Descriptive analyses will be performed. Data evaluated will include: Time to CSF cytologic response (defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations).
Preliminary signals of activity (defined as either suspicious or positive cytology).
Descriptive analyses will be performed. Data evaluated will include: Duration of cytologic response (time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP) and adverse events.
Descriptive analyses will be performed. Data evaluated will include: Neurologic progression-free survival; duration of TTF treatment; overall survival from start of TTF.

Full Information

First Posted
February 14, 2023
Last Updated
April 25, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05746325
Brief Title
Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer
Official Title
Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2023 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (TTFields, digital photos)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Digital Photography
Intervention Description
Digital photographs taken of array placement
Intervention Type
Procedure
Intervention Name(s)
Lumbar Puncture
Other Intervention Name(s)
LP, Spinal Tap
Intervention Description
Undergo LP
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
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
Intervention Description
Undergo MRI
Intervention Type
Device
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Transducer arrays applied and wear NovoTTF-200T
Primary Outcome Measure Information:
Title
Incidence of significant toxicity of tumor treating fields (TTFs)
Description
Will be measured by 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 Cancer Therapy Evaluation Program Active Version Common Terminology Criteria for Adverse Events.
Time Frame
Up to 3 years
Title
Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy
Description
Will be estimated the number of patients who are unable to complete at least 30 days of TTF therapy (a composite average for the 30 days of at least 50% of array 'on' time) divided by the total number of evaluable patients.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP)
Description
Descriptive analyses will be performed. Data evaluated will include: cerebral spinal fluid (CSF) cytologic response; magnetic resonance imaging radiographic response within the TTF field.
Time Frame
Up to 3 years
Title
Preliminary signals of activityby Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP); and adverse events
Description
Descriptive analyses will be performed. Data evaluated will include: Time to CSF cytologic response (defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations).
Time Frame
Up to 3 years
Title
Preliminary signals of activity (defined as either suspicious or positive cytology).
Description
Descriptive analyses will be performed. Data evaluated will include: Duration of cytologic response (time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology).
Time Frame
Up to 3 years
Title
Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP) and adverse events.
Description
Descriptive analyses will be performed. Data evaluated will include: Neurologic progression-free survival; duration of TTF treatment; overall survival from start of TTF.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 25,000/mm^3, and absolute neutrophil count (ANC) greater than 0.5 mm^3 Patients must have adequate liver function, total bilirubin < 2.5 mg%, 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%) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt A Jaeckle
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Kurt A. Jaeckle, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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