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

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ClinicalTrials.gov Identifier: NCT02657460
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Yang Jin, Wuhan Union Hospital, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Biological: tumor derived microparticles Drug: cisplatin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: MTX-ATMPs
methotrexate-autologous tumor derived microparticles
 Biological: tumor derived microparticles
The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
Sham Comparator: cisplatin
Cisplatin is a traditional treatment for lung cancer
 Drug: cisplatin
cisplatin is a traditional drug for lung cancer
Other Name: cisplatinum


Outcome Measures
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Primary Outcome Measures :
  1. Pleural effusions volume [ Time Frame: four weeks ]

Secondary Outcome Measures :
  1. Rivalta Test of pleural effusions [ Time Frame: four weeks ]
  2. total protein level of pleural effusions [ Time Frame: four weeks ]
  3. total karyocytes count of pleural effusions [ Time Frame: four weeks ]
  4. lactic dehydrogenase level of pleural effusions [ Time Frame: four weeks ]
  5. adenosine deaminase level of pleural effusions [ Time Frame: four weeks ]
  6. the cytology test of pleural effusions [ Time Frame: four weeks ]
  7. Karnofsky index [ Time Frame: four weeks ]
  8. survival time [ Time Frame: six month ]
  9. carcino embryonie antigen level in microgramme/L in serum [ Time Frame: four weeks ]
  10. CYFRA21-1 level in ng/mL in serum [ Time Frame: four weeks ]
  11. neuron specific annuals level in microgramme/L in serum [ Time Frame: four weeks ]
  12. squamous cell carcinoma antigen level in ng/mL in serum [ Time Frame: four weeks ]
  13. carcino embryonie antigen level in microgramme/L in pleural effusions [ Time Frame: four weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657460


Contacts
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Contact: Feng Wu, Master 086-13476080943 wufengxiehe@163.com

Locations
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China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yang Jin, doctor    +86 13554361146    whuhjy@sina.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Principal Investigator: Yang Jin, doctor Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
More Information
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Responsible Party: Yang Jin, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02657460    
Other Study ID Numbers: v1.4
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD now
Keywords provided by Yang Jin, Wuhan Union Hospital, China:
chemotherapy
microparticle
malignant pleural effusion
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents