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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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ClinicalTrials.gov Identifier: NCT02135588
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Eastern Regional Medical Center

Brief Summary:
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 Intervention/treatment Phase
Loculated or Non-draining Malignant Pleural Effusions Drug: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : January 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Radiographic improvement in area of pleural collection [ Time Frame: Day 14 ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical failure of small-bore chest tube with persistent pleural effusion
  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:

  1. Prior treatment with intrapleural fibrinolytic agents
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135588


Contacts
Contact: Steven B Standiford, MD 215-537-7400 steven.standiford@ctca-hope.com

Locations
United States, Pennsylvania
Eastern Regional Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Steven B Standiford, MD    215-537-7400    steven.standiford@ctca-hope.com   
Contact: Jack Medendorp    215-537-3160    jack.medendorp@ctca-hope.com   
Principal Investigator: Steven B Standiford, MD         
Sub-Investigator: Emil Abramian, MD         
Sub-Investigator: Jeffrey B Hoag, MD         
Sponsors and Collaborators
Eastern Regional Medical Center
Investigators
Principal Investigator: Steven B Standiford, MD Eastern Regional Medical Center, Inc.

Responsible Party: Eastern Regional Medical Center
ClinicalTrials.gov Identifier: NCT02135588     History of Changes
Other Study ID Numbers: ERMC 13-29
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action