Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

NCT06184321 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: 2021-0554NCI-2021-09122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events

  through study completion; an average of 1 year

Study Arms (2)

Arm I (alteplase)

EXPERIMENTAL

Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.

Biological: Alteplase

Arm II (placebo)

PLACEBO COMPARATOR

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.

Drug: Placebo Administration

Interventions

Alteplase BIOLOGICAL

Instilled into IPC

Also known as: Activase, Plasminogen Activator (Human Tissue-Type Protein Moiety), r-tPA, Recombinant Tissue Plasminogen Activator, rt-PA

Arm I (alteplase)

Placebo Administration DRUG

Instilled into IPC

Arm II (placebo)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Horiana Grosu, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Horiana Grosu, M D

CONTACT

713-792-6238; hbgrosu@mdanderson.org

Study Design

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

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)