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

Last updated: February 27, 2022
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

1

Condition

Brain Metastases

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT04967027
BM V1.0/2020-08-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 hasa 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, brainstimulators, severe intracranial edema, increased intracranial pressure leading tomidline structures exceeding 5 mm, optic nerve head edema, disturbance ofconsciousness, 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 ofnormal 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

Study Design

Total Participants: 5
Study Start date:
August 01, 2020
Estimated Completion Date:
December 01, 2022

Connect with a study center

  • Xiangya Hospital Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

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