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

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04967027
Collaborator
(none)
5
1
1
28
0.2

Study Details

Study Description

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
  • Device: ASCLU-300 TTF
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. The treatment-related adverse events [12 months]

    Number of patients who experienced a treatment-related adverse event.

  2. Time to Progression [12 months]

    Time to progression of patients with brain metastases

  3. Overall Survival Rate [12 months]

    Number of patients alive at 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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 < 100x109/L; F. Absolute neutrophils count < 1x109/L; G. Hemoglobin < 100g/L;

  • other conditions physicians not suggest to take the trial

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiangya Hospital Central South University Changsha Hunan China 410000

Sponsors and Collaborators

  • Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Zhixiong Liu, MD, Xiangya Hospital of Central South University
  • Principal Investigator: Yu Zeng, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT04967027
Other Study ID Numbers:
  • BM V1.0/2020-08-01
First Posted:
Jul 19, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022