Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions
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The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.
Condition or disease
Loculated or Non-draining Malignant Pleural Effusions
Drug: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)
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Ages Eligible for Study:
18 Years to 99 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical failure of small-bore chest tube with persistent pleural effusion
18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
Serum creatinine ≤2.0 times the upper limit of the normal range, total bilirubin ≤ 2.5 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
At least 2 days from administration of chemotherapy
At least 7 days from prior major surgery
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
Patient judged to be 'medically stable' by primary investigator.
Prior treatment with intrapleural fibrinolytic agents
Presence of any intracranial mass
Traumatic hemorrhagic pleural effusion
Major hemorrhage, coincidental stroke, or major trauma
High-risk for systemic bleeding
Allergy or intolerance to dornase alfa
Active clinically serious infection > CTCAE (version 4.03) Grade 2.
Serious non-healing wound, ulcer, or bone fracture.
Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study)