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

Phase 2

• Conditions: Malignant Pleural Effusion
• Interventions: Biological: tumor derived microparticles; Drug: cisplatin

• Registration Number: NCT02657460
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
4. 18-70 years old;
5. 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;
6. agreed to participate in the study and sign an informed consent;
7. without other severe comorbidities.

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Exclusion Criteria

1. lactating or pregnant patients;
2. allergy to multiple drugs;
3. with other severe comorbidities or psychological diseases;
4. severe infection;
5. participation in other clinical trials within the recent three months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTX-ATMPs	tumor derived microparticles	methotrexate-autologous tumor derived microparticles
cisplatin	cisplatin	Cisplatin is a traditional treatment for lung cancer

Primary Outcome Measures

Name	Time	Method
Pleural effusions volume	four weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science & Technology; 🇨🇳 Wuhan, Hubei, China