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

NCT04967027 | Unknown Early Phase 1 DMC

• 1 other identifier: BM V1.0/2020-08-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Keywords

Tumor Treating Fields; Brain metastases;

Outcome Measures

Primary Outcomes (3)

• 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 brain metastases

  12 months

• Overall Survival Rate

  Number of patients alive at 12 months

  12 months

Study Arms (1)

TTFields group

EXPERIMENTAL

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.

Device: ASCLU-300 TTF

Interventions

ASCLU-300 TTF DEVICE

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

TTFields group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zhixiong Liu, MD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Yu Zeng

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fangkun Liu, MD

CONTACT

8615874290600; liufangkun@csu.edu.cn

Liyang Zhang, MD

CONTACT

8613787118459; zhangliyang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 19, 2021
• Study Start: August 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2021-07

Locations

CN (1)