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Combination tissue plasminogen activator (tPA) and dornase alpha (DNase) administration through intrapleural catheters for the treatment of loculated or non-draining malignant pleural effusions

Description

The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to participants with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective is to establish efficacy of tissue plasminogen activator and dornase alfa administered through intrapleural catheters for the treatment of loculated malignant pleural effusions as determined by:

  • Radiographic improvement in area of pleural collection (between the area of  the pleural collection on the ultrasound pre-procedure and ultrasound  evaluation on day 14 (+/-four days)
  • Change in volume output from baseline to day 14 (+/-four days)

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have had a clinical failure of small-bore chest tube with persistent pleural effusion, or had imaging demonstrative of a complex pleural space (loculated effusion) with clinical symptoms
  • Are 18 years of age or older
  • Have Eastern Cooperative Oncology Group performance status score  0-2
  • Have a life expectancy of  ≥ six weeks

Excluding patients who have:

  • Had prior treatment with intrapleural fibrinolytic agents
  • Presence of any intracranial mass
  • Traumatic hemorrhagic pleural effusion
  • Had major hemorrhage, coincidental stroke or major trauma
  • High risk for systemic bleeding