Tumor Electric Fields Treatment System for Glioblastoma

A Prospective, Single-center, Single-arm, Exploratory Study on the Treatment of Recurrent Glioblastoma With Tumor Electric Fields Treatment System

This early phase I trial will investigate the safety and feasibility of applying the Tumor Electric Fields Treatment System to subjects with recurrent glioblastoma.

Study Overview

• Status: Unknown
• Conditions: Glioblastoma
• Intervention / Treatment: Device: Tumor Electric Fields Treatment System

Detailed Description

Subjects who have previously completed radiotherapy and at least two cycles of chemotherapy with imaging or pathological evidence of tumor recurrence will receive Tumor Electric Fields Treatment System. The main objective is to evaluate the safety of applying the Tumor Electric Fields Treatment System to subjects with recurrent GBM.

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

Contacts and Locations

• Study Contact: Name: Zhixiong Liu, M.D.; Phone Number: +8613607318785; Email: zhixiongliu@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 with pathological diagnosis of glioblastoma at first surgery (WHO Grade IV, supratentorial location);
• Age between 18 and 65 years, male or female;
• Previously completed radiotherapy and at least two cycles of chemotherapy;
• With imaging or pathological evidence of tumor recurrence;
• Karnofsky performance score (KPS) score ≥ 70 before intervention;
• With a life expectancy more than 3 months;
• Adopted effective contraceptive measures at child-bearing age;
• Provided written informed consent.

Exclusion Criteria:

• Patients unwilling to use the equipment ≥ 18h per day;
• With poor compliance or live too far from the research center, who cannot keep regular follow-up or adjust the electrode position of the treatment equipment, and who refuse to receive follow-up to terminal survival;
• With poor healing of scalp wound, poor scalp condition, large skull defect or other cases where electrodes are not suitable for wearing;
• Within 3 months from radiotherapy;
• Within 4 weeks from the last cycle of chemotherapy;
• Within 4 weeks from surgery for recurrence;
• Participated in other clinical trials.
• Pregnant;
• Epilepsy symptoms not effectively controlled;
• 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;
• With severe infectious diseases, such as acute severe infection and HIV positive;
• Other conditions, such as an implanted cardiac pacemaker or deep brain stimulator, severe intracranial edema, increased intracranial pressure resulting in midline shift>5mm, clinically significant papilledema, or reduced level of consciousness, allergy to conductive coupling agent, gel, and other serious life-threatening diseases.
• Other circumstances considered inappropriate to participate in the research by the investigator.

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: Tumor Electric Fields Treatment System; Patients have a histologically confirmed diagnosis of supratentorial glioblastoma that is recurrent. All patients will receive Tumor Electric Fields Treatment System.	Device: Tumor Electric Fields Treatment System; Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.; Other Names: ASCLU-300

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 recurrent glioblastoma.	12 months
Overall Survival Rate	Number of patients alive at 12 months.	12 months

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Collaborators: Hunan An Tai Kang Cheng Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 31, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: glioblastoma; tumor electric fields treatment
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 202001012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No