RECRUITING

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients With Breast or Lung Cancer

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Conditions

Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Malignant Neoplasm in the LeptomeningesMetastatic Lung CarcinomaStage IV Lung Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-07
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05746325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18
  2. * Prior tissue diagnosis of breast cancer or lung cancer
  3. * Confirmed diagnosis of leptomeningeal metastases (LM) with positive cerebrospinal fluid (CSF) cytology for malignancy and meningeal enhancement (type 1A, 1B, and 1C)
  4. * Radiographic evidence on MRI of leptomeningeal enhancement within the cervical, thoracic or lumbar spine on spinal MRI
  5. * Life expectancy of at least 6 weeks
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
  7. * Recovery from any neurotoxic effects of prior therapy
  8. * Platelet count greater than 25 x 10\^9/L
  9. * Absolute neutrophil count (ANC) greater than 0.5 x 10\^9/L
  10. * 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 \[calculated estimated glomerular filtration rate (eGFR) \>= 30 mL/min/ body surface area (BSA)\]
  11. * Patients or legal medical representative must provide written informed consent
  12. * Patients must have suitable body habitus for placement of transducer arrays
  13. * Patients must be willing to wear the device for at least 18 hours a day (averaged over monthly)
  14. * Patients must be willing to return for the scheduled evaluations and perform the required assessments
  15. * Patients are without other disease or situation which would significantly compromise adequate assessment of safety and feasibility of the TTF
  16. * Patient willing to start a study treatment with TTF =\< 14 days from registration
  1. * Concomitant therapy:
  2. * 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
  3. * Must not have received radiation therapy (RT) to the brain or spinal cord within 2 weeks of initiation of TTF
  4. * Must be at least 1 week from cessation of any prior intrathecal chemotherapy
  5. * 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)
  6. * Patients with uncontrolled or untreated infection including active hepatitis, and human immunodeficiency virus (HIV)
  7. * 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
  8. * Patients known to be allergic to the hydrophilic gel utilized for transducer attachment
  9. * Patients with surgical hardware within the planned area of treatment in the spine (e.g., titanium rods, screws, fixation devices)

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Wendy J. Sherman, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Wendy J. Sherman, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-07
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-04-07
Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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