Clinical trial NCT06184321: Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Official title: A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Horiana Grosu, M D
role: PRINCIPAL_INVESTIGATOR
References: