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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 2

Conditions: Malignant Pleural Effusion

Treatments: Biological: tumor derived microparticles; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02657460

v1.4

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

MTX-ATMPs

Experimental group

Description:

methotrexate-autologous tumor derived microparticles

Treatment:

Biological: tumor derived microparticles

cisplatin

Sham Comparator group

Description:

Cisplatin is a traditional treatment for lung cancer

Treatment:

Drug: cisplatin