Alteplase for Cancer-Related Pleural Effusion
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a drug called alteplase can aid individuals with malignant pleural effusion, a condition where fluid accumulates around the lungs, causing breathing difficulties. Typically used to dissolve blood clots, alteplase might facilitate fluid drainage and improve breathing. Participants will receive either alteplase or a placebo (a substance with no active drug) through a chest catheter. Those who often struggle with fluid drainage around their lungs and experience breathlessness may be suitable for this study. As an Early Phase 1 trial, this research aims to understand how alteplase functions in people, offering participants a chance to contribute to groundbreaking medical knowledge.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that alteplase, a drug used to dissolve blood clots, is generally safe but can cause bleeding, the most common side effect for similar drugs. Most bleeding is minor, but serious bleeding can occur in some cases. Bleeding may happen internally or on the skin, especially at needle sites. Despite these risks, alteplase is approved for treating heart attacks, strokes, and lung clots, indicating its safety is well understood for these uses. However, its use for fluid around the lungs (pleural effusion) remains under study.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about using alteplase for managing symptomatic septated malignant pleural effusion because it offers a unique approach by directly targeting the pleural space through an indwelling catheter. Unlike traditional treatments that might involve systemic therapy, this method delivers alteplase—a clot-dissolving enzyme—directly where it's needed, potentially breaking down the septations that hinder fluid drainage. This targeted delivery could lead to quicker relief of symptoms and improved drainage efficiency compared to standard care methods. Additionally, the ability to administer alteplase locally with minimal systemic exposure may reduce side effects typically associated with more generalized treatments.
What evidence suggests that alteplase might be an effective treatment for malignant pleural effusion?
Research has shown that alteplase, which participants in this trial may receive, can help treat pleural effusions, or fluid buildups around the lungs. One study found that over 70% of patients experienced fluid clearance after three doses of alteplase. Another report indicated a 70% to 80% success rate in maintaining catheter function and improving fluid drainage. Alteplase works by breaking down clots, enhancing drainage, and relieving symptoms like breathlessness. These findings suggest that alteplase could be a promising option for managing lung fluid buildup.678910
Who Is on the Research Team?
Horiana Grosu, M D
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive either alteplase or placebo instilled into the IPC, which is capped for 1-2 hours before the catheter is drained
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alteplase
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Re‐establishing indwelling pleural catheter patency with ...
We used a single dose of 2.5 mg IP alteplase which was successful in establishing patency of the IPC and draining the effusion. This case ...
A CASE OF INDWELLING PLEURAL CATHETER (IPC)
The patient received intrapleural tissue plasminogen activator (tPA) with DNAse according to hospital's protocol (10mg alteplase with 5mg DNase ...
A double blind randomized cross over trial comparing rate ...
All patients treated with three doses of Alteplase had over 70% resolution of their effusions and three patients that failed Alteplase therapy recurred only ...
Effectiveness and Risks Associated With Intrapleural ...
In my former institution at the University of Cincinnati, we had similar results, about a 70% to 80% success rate, but we used 6 mg in 50 of them. We didn't see ...
Alteplase Through an Indwelling Pleural Catheter for the ...
To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated ...
Safety Profile - Cathflo® Activase® (alteplase)
The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Cathflo Activase has not been studied in patients ...
Cathflo Activase Side Effects: Common, Severe, Long Term
Alteplase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people.
Important Safety Information | Activase® (Alteplase)
Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites.
CATHFLO ACTIVASE® Vials (2 mg)
Chronic aquatic toxicity. : This product has no known ecotoxicological effects. Toxicity Data on Soil. : Not expected to adsorb on soil. Other ...
Alteplase (CathFlo Activase), Genentech, Package Insert
There were no gender-related differences observed in the rates of adverse. 259 reactions. Adverse reactions profiles were similar across age subgroups,. 260 but ...
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