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Phase 1 Trial for Tumor Treating Field for Drug/Radiation Resistant Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04967027
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief Summary:
Brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(BM), up to 40% by autopsy. Great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. Tumor treating fields (TTFields) is one of the standard combination treatment for GBM, and some researchers believe that TTFields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. In this study, the investigator attempts to evaluate the safety, and tolerability of TTFields in adult participants diagnosed with Drug/Radiation resistant BM.

Condition or disease Intervention/treatment Phase
Brain Metastases Device: ASCLU-300 TTF Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Safety and Tolerability of TTFields for Patients With Brain Metastases After the Standard Treatment Fails: a Prospective, Single-center, Single-arm Study
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Arm Intervention/treatment
Experimental: TTFields group
patients with brain metastases who have been resistant to drug or radiation therapy, to be treated by continuous TTFields treatment using the ASCLU-300 TTF device.
Device: ASCLU-300 TTF
BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)

Primary Outcome Measures :
  1. The treatment-related adverse events [ Time Frame: 12 months ]
    Number of patients who experienced a treatment-related adverse event.

  2. Time to Progression [ Time Frame: 12 months ]
    Time to progression of patients with brain metastases

  3. Overall Survival Rate [ Time Frame: 12 months ]
    Number of patients alive at 12 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team;
  • age from 18 to 65 year-old;
  • patients have been progressed from standard therapy (drug/radiation resistance)
  • KPS more than 70 score;
  • anticipated OS more than 3 months;
  • signed consent form.

Exclusion Criteria:

  • unable to take TTFields more than 18 hours each day;
  • unable to follow-up till progression;
  • the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes
  • pregnant women;
  • last drug within 4 weeks, last radiation within 3 months, take other trials;
  • other heavy diseases like heavy infection;
  • other condition: Such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc.
  • blood and biochemical indicators in the following range: A. Liver function impairment: AST or ALT > 3 times the upper limit of normal; B. Total bilirubin> upper limit of normal value; C. Renal impairment: serum creatinine>1.7mg /dL (>150 mol/L); D. Coagulopathy: PT or APTT >1.5 times normal; E. Platelets counts < 100x10^9/L; F. Absolute neutrophils count < 1x10^9/L; G. Hemoglobin < 100g/L;
  • other conditions physicians not suggest to take the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04967027

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Contact: Fangkun Liu, MD 8615874290600
Contact: Yu Zeng, MD 8618774051768

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China, Hunan
Xiangya Hospital Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Zhixiong Liu, M.D.    +8613607318785   
Sponsors and Collaborators
Xiangya Hospital of Central South University
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Principal Investigator: Zhixiong Liu, MD Xiangya Hospital of Central South University
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Responsible Party: Xiangya Hospital of Central South University Identifier: NCT04967027    
Other Study ID Numbers: BM V1.0/2020-08-01
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: due to protect the patients' privacy, we have not yet decided to share each IPD, but we can share IPD once other researchers request upon approval by our Ethics Committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
Tumor Treating Fields; Brain metastases;
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Neoplastic Processes
Pathologic Processes
Brain Diseases
Nervous System Diseases