Tumor Electric Fields Treatment System for Glioblastoma

NCT ID: NCT04417933

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-07
• Study Completion Date: 2021-05-31

Brief 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.

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tumor Electric Fields Treatment System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ASCLU-300

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan An Tai Kang Cheng Biotechnology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhixiong Liu, M.D.

Role: CONTACT

zhixiongliu@csu.edu.cn

+8613607318785

Facility Contacts

Zhixiong Liu, M.D.

Role: primary

zhixiongliu@csu.edu.cn

+8613607318785

Other Identifiers

202001012

Identifier Type: -

Identifier Source: org_study_id