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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Tolerability of TTFields for Patients With Brain Metastases After the Standard Treatment Fails: a Prospective, Single-center, Single-arm Study

Conditions
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Brain Metastases

Intervention / Treatment
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* Device: ASCLU-300 TTF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTFields group<br>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<br>* BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The treatment-related adverse events | Number of patients who experienced a treatment-related adverse event. | 12 months | 
| Time to Progression | Time to progression of patients with brain metastases | 12 months | 
| Overall Survival Rate | Number of patients alive at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor Treating Fields; Brain metastases;