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New treatment option for Anatomic Stage IV Breast Cancer AJCC v8
Official title Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer
ClinicalTrials.gov ID: NCT05746325
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
- Life expectancy of at least 6 weeks
You likely can't join if
- 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...
- 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...
- Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
See the full eligibility 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 \ = 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
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.