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| ID | Type | Description | Link |
|---|---|---|---|
| 21-005732 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Photography | Other | Digital photographs taken of array placement |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary signals of activity - CSF cytologic response | Descriptive analyses will be performed to assess preliminary signals of activity. CSF cytologic response will be assessed for patients who had positive CSF cytology at baseline. | Up to 3 years |
| Preliminary signals of activity - MRI radiographic response |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant therapy:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wendy J. Sherman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Lumbar Puncture | Procedure | Undergo LP |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Medical Device Usage and Evaluation | Device | Transducer arrays applied and wear NovoTTF-200T |
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| Biospecimen Collection | Procedure | Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously |
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Descriptive analyses will be performed. Assessed by MRI radiographic response within the TTF field |
| Up to 3 years |
| Preliminary signals of activity - time to CSF cytologic repsonse | Descriptive analyses will be performed. Assessed by time to CSF cytologic response (patients with positive baseline CSF cytology only), defined as the date of initiation of TTF to the last date of three consecutive negative CSF cytologic examinations). | Up to 3 years |
| Preliminary signals of activity - duration of CSF cytologic response | Descriptive analyses will be performed. Assessed by time from the date of the third consecutive negative CSF to CSF cytologic relapse (defined as either suspicious or positive cytology). | Up to 3 years |
| Preliminary signals of activity - neurologic progression-free survival | Descriptive analyses will be performed. Assessed by neurologic progression-free survival, the time from study enrollment to documented worsening of neurological symptoms or signs of disease progression. | Up to 3 years |
| 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). | Up to 3 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D055756 | Meningeal Carcinomatosis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| D009682 | Magnetic Resonance Spectroscopy |
| D010808 | Physical Examination |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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