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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases
• Intervention / Treatment: Device: ASCLU-300 TTF

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Fangkun Liu, MD; Phone Number: 8615874290600; Email: liufangkun@csu.edu.cn
• Study Contact Backup: Name: Liyang Zhang, MD; Phone Number: 8613787118459; Email: zhangliyang@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Zhixiong Liu, M.D.; Phone Number: +8613607318785; Email: zhixiongliu@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Tumor Treating Fields; Brain metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: BM V1.0/2020-08-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No