Talc Instillation in Addition to Daily Drainage Through a Tunneled Pleural Catheter to Improve Rates of Outpatient Pleurodesis in Patients with Malignant Pleural Effusion, The ASAP II Trial

Inclusion Criteria

• Male or female, at least 18 years of age, inclusive
• Subject has a symptomatic malignant pleural effusion (MPE) requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true: * There is histocytological confirmation of pleural malignancy * The effusion is an exudate (per Light’s criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
• Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved
• Subject is willing and able to provide written informed consent
• Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls
• Subject has sufficient pleural fluid to allow safe insertion of an indwelling pleural catheter (IPC)
• Subject has negative pregnancy test if appropriate
• Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member, or paid healthcare professional)

Exclusion Criteria

• Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, two separate study center clinicians must agree that there is no significant trapped lung on the same chest x-ray (CXR) using visual estimation (reference guide). The CXR used to make this decision must have been performed =< 30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after tunneled pleural catheter insertion. Significant trapped lung is deemed present if any 1 of the following criteria is met: * A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and pleural line) apical pneumothoraces. * A CXR shows >= 20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid * A CXR shows >= 20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough)
• Subject has a Karnofsky score < 50, or a World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status >= 3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more
• Subject is pregnant, planning to become pregnant, or is lactating
• Subject has a history of empyema
• Subject has a history of chylothorax
• Subject has an uncorrected coagulopathy