Trial record 3 of 10 for:    MALIGNANT PLEURAL EFFUSION MARYLAND

The BLAST Trial- Biomarker Levels During Indwelling Pleural cAtheter Sample Testing

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Lonny Yarmus, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02092155
First received: March 17, 2014
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Some patients that have a tunneled pleural catheter will not have the pleural fluid (water around the lung) return after some time (pleurodesis). The purpose of this study is to understand how the investigators can predict who will achieve pleurodesis and how this occurs by studying the pleural effusion.


Condition Intervention
Malignant Pleural Effusions
Device: Rocket Indwelling Pleural Catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biomarker Levels During Indwelling Pleural Catheter Sample

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • To determine the median time to pleurodesis [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    Duration of follow-up will be 12 weeks. After 12 weeks, all patients who do not achieve spontaneous pleurodesis will adhere to the standard drainage protocol.


Secondary Outcome Measures:
  • TGF-B levels over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine the threshold TGF-B level to determine accuracy of predicting auto-pleurodesis


Estimated Enrollment: 95
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Indwelling tunneled pleural catheter Device: Rocket Indwelling Pleural Catheter
No Intervention: TGF-β markers

Detailed Description:

An alternative and emerging treatment for malignant pleural effusions is the placement of a chronic indwelling pleural catheter such as the Rocket® catheter. The Rocket® catheter is a 16 French, 66 cm long, silicone catheter with side holes along its distal 24 cm. The proximal shaft has a polyester cuff designed to promote fibrosis in the subcutaneous tissue into which it is tunneled. This prevents dislodgement of the catheter and minimizes the risk of infection. The proximal end contains a self-sealing valve designed to enhance the safety of the catheter. The self-sealing valve prevents entry of air into the pleural space and inadvertent leakage of pleural fluid unless the catheter is accessed with the matched drainage line. The matched drainage line is connected to a 600 milliliter vacuum bottle. Pleural fluid is removed by inserting the access tip of the drainage line into the self-sealing valve of the Rocket® catheter, allowing vacuum drainage of the pleural space.

As discussed above, tunneled pleural catheters (TPC) are ideal for treatment of MPE associated with a trapped or non-expandable lung which will not have sufficient visceral and parietal pleura apposition for chemical pleurodesis. Transforming growth factor-Beta 1 (TGF-β) is a profibrotic cytokine, and a potent inducer of Plasminogen activator inhibitor-1 (PAI-1) in human pleural mesothelial cells. PAI-1 inhibits protease-dependent fibrinolytic activity and along with TGF-β, its concentration is increased in exudative and tuberculous pleural effusion. TGF-β levels in pleural fluid have been shown to correlate with pleural thickness in tuberculosis pleurisy and empyema in rabbits.

TGF-β is a multifunctional cytokine primarily produced by mesothelial cells in the pleural space, but can also originate from lung parenchymal macrophages that migrate to the pleural space. In humans, TGF-β consists of three isoforms (TGF-β1, TGF-β2, and TGF-β3). They share many biological activities and their actions on cells are qualitatively similar in most cases. TGF-β stimulates the extracellular matrix production and studies support that TGF-β over-production is a key regulator in pleural fibrosis and chemical pleurodesis. Moreover, TGF-β signaling for the production of PAI-1 is clearly noted in human mesothelial cells of different origins. Different inflammatory stimuli in the pleural space including malignancy and infection may activate TGF-β up-regulation and enhanced production which in turns results in PAI-1 expression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Pleural effusion (etiology fulfilling one of the following criteria):

    1. Malignant effusion confirmed by cytology or pleural biopsy
    2. exudative effusion in the setting of known malignancy with no other identifiable cause
    3. Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy
  • 18 years of age
  • Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort
  • Demonstration of symptomatic improvement after therapeutic thoracentesis
  • Recurrent pleural effusion after therapeutic thoracentesis
  • Capacity to provide informed consent

Exclusion criteria:

  • Projected life expectancy less than 30 days.
  • Radiographic evidence of trapped lung - persistent lung collapse with failure of the majority (>50%) of the lung to reexpand following drainage of a pleural effusion
  • Previous lobectomy or pneumonectomy on the affected side
  • Patient receiving intrapleural chemotherapy
  • Chylothorax - pleural effusion with triglyceride levels > 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct
  • Parapneumonic effusion - pleural effusion associated with pneumonia
  • Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture
  • Inability to adequately perform pleural drainage at home
  • Uncorrectable bleeding disorder
  • Skin infection at the site of intended catheter insertion
  • Pregnant women - detected by spot urine testing prior to the procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092155

Contacts
Contact: Karen Oakjones-Burgess 410-955-5288 kfriel2@jhmi.edu
Contact: Ricardo Ortiz 410-955-5288 rortiz7@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Karen Oakjones-Burgess    410-955-5288      
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lonny Yarmus, DO Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lonny Yarmus, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02092155     History of Changes
Other Study ID Numbers: NA_00086126
Study First Received: March 17, 2014
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 29, 2014