Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draining/inadequately draining indwelling pleural catheter (IPC). SECONDARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained. ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.
Interventions
BIOLOGICALAlteplase
Instilled into IPC
DRUGPlacebo Administration
Instilled into IPC
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Referral to pulmonary services for inability to drain fully via IPC * Presence of a symptomatic septated pleural effusion * A pleural effusion of significant moderate to large volume based on: * Chest radiograph: effusion filling \>= 1/3 of the hemithorax, or * Computed tomography (CT)-scan: AP depth of the effusion \>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or * Ultrasound: effusion spanning at least three intercostal spaces, with a \>= 3 cm in at least one intercostal space, while the patient sits upright * Age \> 18 * Borg score \>= 3 * Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance * Presence of septated effusion based on ultrasound (US) and chest CT
Exclusion criteria
* Inability to provide informed consent * Study subject has any disease or condition that interferes with safe completion of the study including: * Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures. * Active bleeding * Known allergic reaction to thrombolytics * Pleural effusion is smaller than expected on bedside pre-procedure ultrasound * No septations and/or no loculations on bedside pre-procedure ultrasound * Patient is asymptomatic * Blocked IPC as determined by saline flush
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events | through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTHoriana Grosu, M D
PRINCIPAL_INVESTIGATORHoriana Grosu, M D
M.D. Anderson Cancer Center
Outcome results
None listed