Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions

NCT02135588 | Unknown Phase 1

• 1 other identifier: ERMC 13-29
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Loculated or Non-draining Malignant Pleural Effusions

Outcome Measures

Primary Outcomes (1)

• Radiographic improvement in area of pleural collection

  Day 14

Study Arms (1)

Active Treatment

EXPERIMENTAL

Intra-pleural deoxyribonuclease 5mg and intra-pleural Alteplase 10mg, every 12 hours over 72 hours (total of 6 treatments)

Drug: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)

Interventions

Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) DRUG

Active Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical failure of small-bore chest tube with persistent pleural effusion
• years of age or older
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
• Life expectancy ≥ 6 weeks
• Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
• 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.

You may not qualify if:

• 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)
• Expected survival less than six weeks

Sponsors & Collaborators

• Eastern Regional Medical Center: lead

Study Sites (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

RECRUITING

MeSH Terms

Interventions

dornase alfa

Study Officials

• Steven B Standiford, MD

  Eastern Regional Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven B Standiford, MD

CONTACT

215-537-7400; steven.standiford@ctca-hope.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

US (1)