Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases Involving the Spine

Plain English Summary

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer is a Not Applicable clinical trial sponsored by Mayo Clinic studying 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. This study tests a device called Tumor Treating Fields (TTFields) to treat cancer that has spread to the spinal fluid. It is for patients with breast or lung cancer that has spread to the spinal fluid and spine. Participants will wear a device that generates electric fields to target cancer cells, and will undergo regular medical assessments. Alternative treatments may include chemotherapy, radiation, or other targeted therapies, depending on the patient's specific situation. The trial aims to enroll 5 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 18 or older with a confirmed diagnosis of leptomeningeal metastases (cancer in the spinal fluid) from breast or lung cancer. Patients must have evidence of cancer spread in their spinal fluid and on spinal MRI, and a life expectancy of at least 6 weeks. Individuals with certain pre-existing health conditions, such as uncontrolled infections or allergies to device components, may not be eligible. Patients must be willing to wear the device for at least 18 hours a day and return for scheduled appointments. This trial is studying 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, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the TTFields device is and whether patients can complete the prescribed treatment duration, indicating its potential for future use. The specific primary outcome measures are: Incidence of significant toxicity of tumor treating fields (TTFs) (Up to 3 years); Feasibility of TTFs - completion of at least 28 days of TTF therapy (Up to 28 days). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial explores a novel non-invasive treatment option for leptomeningeal metastases, a challenging complication of breast and lung cancer that currently has limited effective treatments. This research targets 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, where improved treatment options are needed.

Investor Insight

This pilot study addresses a significant unmet need in advanced cancer care, potentially opening a new therapeutic avenue for a difficult-to-treat condition.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of TTFields, and how it compares to other treatment options. Participation involves wearing a device with adhesive pads on your back for at least 18 hours a day and attending regular clinic visits for assessments. You will undergo procedures like spinal taps and MRIs to monitor your condition and the treatment's effects. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 5 participants

Interventions

• OTHER: Digital Photography — Digital photographs taken of array placement
• PROCEDURE: Lumbar Puncture — Undergo LP
• PROCEDURE: Magnetic Resonance Imaging — Undergo MRI
• DEVICE: Medical Device Usage and Evaluation — Transducer arrays applied and wear NovoTTF-200T
• PROCEDURE: Biospecimen Collection — Undergo collection of cerebrospinal fluid (CSF) during screening if no CSF testing for malignancy has been done previously

Primary Outcomes

• Incidence of significant toxicity of tumor treating fields (TTFs) (Up to 3 years)
• Feasibility of TTFs - completion of at least 28 days of TTF therapy (Up to 28 days)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

* 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
* 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)

Trial Locations

• Mayo Clinic in Florida, Jacksonville, Florida, United States

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Lung Cancer
• Leptomeningeal Metastases
• Metastatic Cancer
• Spinal Cord Tumors
• Central Nervous System Metastases
• Oncology
• Cancer Treatment
• Palliative Care
• Neurology

More Anatomic Stage IV Breast Cancer AJCC v8 Trials

View all Anatomic Stage IV Breast Cancer AJCC v8 clinical trials