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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Wuhan Union Hospital, China

Current Primary Outcome: Pleural effusions volume [ Time Frame: four weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Wuhan Union Hospital, China

Dates:
Date Received: January 11, 2016
Date Started: January 2016
Date Completion: December 2018
Last Updated: November 1, 2016
Last Verified: November 2016