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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2022
  • participants needed
    5
  • sponsor
    Xiangya Hospital of Central South University
Updated on 25 July 2021

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.

Details
Condition Brain Metastasis, Brain Metastases
Treatment ASCLU-300 TTF
Clinical Study IdentifierNCT04967027
SponsorXiangya Hospital of Central South University
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

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
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