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

Central South University

Status and phase: Unknown; Early Phase 1

Conditions: Brain Metastases

Treatments: Device: ASCLU-300 TTF

Study type: Interventional

Funder types: Other

Identifiers

NCT04967027

BM V1.0/2020-08-01

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

TTFields group

Experimental group

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.

Treatment:

Device: ASCLU-300 TTF