Clinical trial NCT04967027: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Brain Metastases
Keywords: Tumor Treating Fields; Brain metastases;
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: The treatment-related adverse events
timeFrame: 12 months
measure: Time to Progression
timeFrame: 12 months
measure: Overall Survival Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Zhixiong Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Hospital of Central South University
name: Yu Zeng
role: PRINCIPAL_INVESTIGATOR
References: