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Trial record 1 of 1 for:    Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine
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Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT05746325
Recruitment Status : Recruiting
First Posted : February 27, 2023
Last Update Posted : February 22, 2024
Sponsor:
Information provided by (Responsible Party):
Kurt Jaeckle, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma Metastatic Malignant Neoplasm in the Leptomeninges Other: Digital Photography Procedure: Lumbar Puncture Procedure: Magnetic Resonance Imaging Device: Medical Device Usage and Evaluation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine
Actual Study Start Date : April 7, 2023
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
Other: Digital Photography
Digital photographs taken of array placement

Procedure: Lumbar Puncture
Undergo LP
Other Names:
  • LP
  • Spinal Tap

Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • 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

Device: Medical Device Usage and Evaluation
Transducer arrays applied and wear NovoTTF-200T




Primary Outcome Measures :
  1. Incidence of significant toxicity of tumor treating fields (TTFs) [ Time Frame: Up to 3 years ]
    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.

  2. Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy [ Time Frame: Up to 30 days ]
    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 :
  1. Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP) [ Time Frame: Up to 3 years ]
    Descriptive analyses will be performed. Data evaluated will include: cerebral spinal fluid (CSF) cytologic response; magnetic resonance imaging radiographic response within the TTF field.

  2. 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 [ Time Frame: Up to 3 years ]
    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).

  3. Preliminary signals of activity (defined as either suspicious or positive cytology). [ Time Frame: Up to 3 years ]
    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).

  4. 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. [ Time Frame: Up to 3 years ]
    Descriptive analyses will be performed. Data evaluated will include: Neurologic progression-free survival; duration of TTF treatment; overall survival from start of TTF.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05746325


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Kurt A. Jaeckle, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Kurt A Jaeckle, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Kurt Jaeckle, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT05746325    
Other Study ID Numbers: MC210303
NCI-2023-00240 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
21-005732 ( Other Identifier: Mayo Clinic Institutional Review Board )
First Posted: February 27, 2023    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases