Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

Study Overview
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Brief Summary
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The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

Detailed Description
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Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.

Official Title
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Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Biological: tumor derived microparticles
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology; The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes; stable vital sign with KPS(Karnofsky Performance Status) index more than 60; 18-70 years old; normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG; agreed to participate in the study and sign an informed consent; without other severe comorbidities. Exclusion Criteria: lactating or pregnant patients; allergy to multiple drugs; with other severe comorbidities or psychological diseases; severe infection; participation in other clinical trials within the recent three months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MTX-ATMPs<br>methotrexate-autologous tumor derived microparticles | Biological: tumor derived microparticles<br>* The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.<br>|
| Sham Comparator: cisplatin<br>Cisplatin is a traditional treatment for lung cancer | Drug: cisplatin<br>* cisplatin is a traditional drug for lung cancer<br>* Other names: cisplatinum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pleural effusions volume |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivalta Test of pleural effusions |  | four weeks | 
| total protein level of pleural effusions |  | four weeks | 
| total karyocytes count of pleural effusions |  | four weeks | 
| lactic dehydrogenase level of pleural effusions |  | four weeks | 
| adenosine deaminase level of pleural effusions |  | four weeks | 
| the cytology test of pleural effusions |  | four weeks | 
| Karnofsky index |  | four weeks | 
| survival time |  | six month | 
| carcino embryonie antigen level in microgramme/L in serum |  | four weeks | 
| CYFRA21-1 level in ng/mL in serum |  | four weeks | 
| neuron specific annuals level in microgramme/L in serum |  | four weeks | 
| squamous cell carcinoma antigen level in ng/mL in serum |  | four weeks | 
| carcino embryonie antigen level in microgramme/L in pleural effusions |  | four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, microparticle, malignant pleural effusion