Phase 1 Trial for Tumor Treating Field for Drug/Radiation Resistant Brain Metastases
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TTFields group 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
BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)
|
Outcome Measures
Primary Outcome Measures
- The treatment-related adverse events [12 months]
Number of patients who experienced a treatment-related adverse event.
- Time to Progression [12 months]
Time to progression of patients with brain metastases
- Overall Survival Rate [12 months]
Number of patients alive at 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients are diagnosed as brain metastases by Xiangya Hospital multidisciplinary team;
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age from 18 to 65 year-old;
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patients have been progressed from standard therapy (drug/radiation resistance)
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KPS more than 70 score;
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anticipated OS more than 3 months;
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signed consent form.
Exclusion Criteria:
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unable to take TTFields more than 18 hours each day;
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unable to follow-up till progression;
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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
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pregnant women;
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last drug within 4 weeks, last radiation within 3 months, take other trials;
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other heavy diseases like heavy infection;
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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.
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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 < 100x109/L; F. Absolute neutrophils count < 1x109/L; G. Hemoglobin < 100g/L;
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other conditions physicians not suggest to take the trial
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Xiangya Hospital Central South University | Changsha | Hunan | China | 410000 |
Sponsors and Collaborators
- Xiangya Hospital of Central South University
Investigators
- Principal Investigator: Zhixiong Liu, MD, Xiangya Hospital of Central South University
- Principal Investigator: Yu Zeng, Xiangya Hospital of Central South University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BM V1.0/2020-08-01