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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

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Pleural effusions volume [ Time Frame: four weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02657460 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Rivalta Test of pleural effusions [ Time Frame: four weeks ]
  • total protein level of pleural effusions [ Time Frame: four weeks ]
  • total karyocytes count of pleural effusions [ Time Frame: four weeks ]
  • lactic dehydrogenase level of pleural effusions [ Time Frame: four weeks ]
  • adenosine deaminase level of pleural effusions [ Time Frame: four weeks ]
  • the cytology test of pleural effusions [ Time Frame: four weeks ]
  • Karnofsky index [ Time Frame: four weeks ]
  • survival time [ Time Frame: six month ]
  • carcino embryonie antigen level in microgramme/L in serum [ Time Frame: four weeks ]
  • CYFRA21-1 level in ng/mL in serum [ Time Frame: four weeks ]
  • neuron specific annuals level in microgramme/L in serum [ Time Frame: four weeks ]
  • squamous cell carcinoma antigen level in ng/mL in serum [ Time Frame: four weeks ]
  • carcino embryonie antigen level in microgramme/L in pleural effusions [ Time Frame: four weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
Official Title  ICMJE Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE
  • 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
    Other Name: cisplatinum
Study Arms  ICMJE
  • Experimental: MTX-ATMPs
    methotrexate-autologous tumor derived microparticles
    Intervention: Biological: tumor derived microparticles
  • Sham Comparator: cisplatin
    Cisplatin is a traditional treatment for lung cancer
    Intervention: Drug: cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Feng Wu, Master 086-13476080943 wufengxiehe@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657460
Other Study ID Numbers  ICMJE v1.4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share IPD now
Responsible Party Yang Jin, Wuhan Union Hospital, China
Study Sponsor  ICMJE Wuhan Union Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yang Jin, doctor Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
PRS Account Wuhan Union Hospital, China
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP