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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06184321
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alteplase — BIOLOGICAL
    Instilled into IPC
  • Placebo Administration — DRUG
    Instilled into IPC

Study Details

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.

Key Dates

Start date
Aug 17, 2023
Status verified
Dec 2025
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (alteplase)
    Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
  • Placebo Comparator: Arm II (placebo)
    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.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Horiana Grosu, MD
[email protected]
713-792-6238
Horiana Grosu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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