Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions
NCT ID: NCT02135588
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2013-10-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active Treatment
Intra-pleural deoxyribonuclease 5mg and intra-pleural Alteplase 10mg, every 12 hours over 72 hours (total of 6 treatments)
Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)
Interventions
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Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)
Eligibility Criteria
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Inclusion Criteria
2. 18 years of age or older
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
4. Life expectancy ≥ 6 weeks
5. Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
6. 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
7. At least 2 days from administration of chemotherapy
8. At least 7 days from prior major surgery
9. 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.
10. Patient judged to be 'medically stable' by primary investigator.
Exclusion Criteria
2. Presence of any intracranial mass
3. Traumatic hemorrhagic pleural effusion
4. Major hemorrhage, coincidental stroke, or major trauma
5. High-risk for systemic bleeding
6. Allergy or intolerance to dornase alfa
7. Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
8. Serious non-healing wound, ulcer, or bone fracture.
9. Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
10. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
11. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
12. Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study)
13. Expected survival less than six weeks
18 Years
99 Years
ALL
No
Sponsors
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Eastern Regional Medical Center
OTHER
Responsible Party
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Principal Investigators
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Steven B Standiford, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Regional Medical Center, Inc.
Locations
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Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ERMC 13-29
Identifier Type: -
Identifier Source: org_study_id
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