Clinical trial NCT05746325: 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
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Malignant Neoplasm in the Leptomeninges
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Incidence of significant toxicity of tumor treating fields (TTFs)
timeFrame: Up to 3 years
measure: Feasibility of TTFs - estimated the number of patients who are unable to complete at least 30 days of TTF therapy
timeFrame: Up to 30 days
Secondary outcomes:
measure: Preliminary signals of activity by Leptomeningeal Assessment in Neuro-Oncology scoring and the M. D. Anderson Symptom Inventory -spine module data (MDASI-SP)
timeFrame: Up to 3 years
measure: 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
timeFrame: Up to 3 years
measure: Preliminary signals of activity (defined as either suspicious or positive cytology).
timeFrame: Up to 3 years
measure: 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.
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Wendy J. Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: