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

Primary Purpose

Brain Metastases

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

ASCLU-300 TTF

About this trial

This is an interventional device feasibility trial for Brain Metastases focused on measuring Tumor Treating Fields; Brain metastases;

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TTFields group

Arm Description

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.

Outcomes

Primary Outcome Measures

The treatment-related adverse events

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

Time to Progression

Time to progression of patients with brain metastases

Overall Survival Rate

Number of patients alive at 12 months

Secondary Outcome Measures

Full Information

NCT ID

NCT04967027

First Posted

July 4, 2021

Last Updated

February 27, 2022

Sponsor

Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT04967027

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

August 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Metastases

Keywords

Tumor Treating Fields; Brain metastases;

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TTFields group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

ASCLU-300 TTF

Intervention Description

BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)

Primary Outcome Measure Information:

Title

The treatment-related adverse events

Description

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

Time Frame

12 months

Title

Time to Progression

Description

Time to progression of patients with brain metastases

Time Frame

12 months

Title

Overall Survival Rate

Description

Number of patients alive at 12 months

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fangkun Liu, MD

Phone

8615874290600

liufangkun@csu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Liyang Zhang, MD

Phone

8613787118459

zhangliyang@csu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhixiong Liu, MD

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yu Zeng

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangya Hospital Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhixiong Liu, M.D.

Phone

+8613607318785

zhixiongliu@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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

Learn more about this trial

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

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