Tumor Electric Fields Treatment System for Glioblastoma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04417933
• Other study ID #: 202001012
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 7, 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: Xiangya Hospital of Central South University
• Contact: Zhixiong Liu, M.D.
• Phone: +8613607318785
• Email: zhixiongliu[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University	Hunan An Tai Kang Cheng Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The treatment-related adverse events	Number of patients who experienced a treatment-related adverse event.	12 months
Primary	Time to Progression	Time to progression of patients with recurrent glioblastoma.	12 months
Primary	Overall Survival Rate	Number of patients alive at 12 months.	12 months