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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967027
• Other study ID #: BM V1.0/2020-08-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2021
• Source: Xiangya Hospital of Central South University
• Contact: Fangkun Liu, MD
• Phone: 8615874290600
• Email: liufangkun[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Device:
• ASCLU-300 TTF
BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

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 brain metastases	12 months
Primary	Overall Survival Rate	Number of patients alive at 12 months	12 months