Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to determine the safety and efficacy of TNK infusion for the treatment of loculated pleural effusions in patients with known malignancy compared to normal saline infusion.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Genentech, Inc.
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• Age > 18 years

• Adult, non-gravid patients with malignancy and symptomatic loculated pleural effusion who has undergone percutaneous drainage will be eligible to participate. A loculated effusion is defined as an effusion whose contents cannot be completely drained at the time of initial catheter placement as documented by the initial imaging guided procedure or within 48 hours of catheter placement by chest radiography. Malignant cells need not be found within the pleural fluid.

Exclusion Criteria:

• Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts

• History of stroke within 3 months

• Intracranial neoplasm, arteriovenous malformation, or aneurysm.

• Uncorrectable bleeding diathesis (INR > 1.5 despite therapy)

• Recent intracranial or intraspinal surgery or trauma

• Pregnancy (positive pregnancy test)

• Severe uncontrolled hypertension

• Documented empyema

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another simultaneous medical investigation or trial

• Participation in another clinical investigation within previous 30 days of catheter placement

• Prior enrollment in the study

• Known allergy to TNK or any of its components