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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02657460
• Other study ID #: v1.4
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: Wuhan Union Hospital, China
• Contact: Feng Wu, Master
• Phone: 086-13476080943
• Email: wufengxiehe[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Biological:
• tumor derived microparticles
The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.

Drug:
• cisplatin
cisplatin is a traditional drug for lung cancer

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

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