Loculated or Non-draining Malignant Pleural EffusionsPhase 1NCT02135588
Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions
A Phase 1 study testing Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) in people with Loculated or Non-draining Malignant Pleural Effusions, run by Eastern Regional Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Loculated or Non-draining Malignant Pleural Effusions
- What is being tested?
- Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical failure of small-bore chest tube with persistent pleural effusion
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
- Life expectancy ≥ 6 weeks
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
- Serum creatinine ≤2.0 times the upper limit of the normal range, total bilirubin ≤ 2.5 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
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- At least 2 days from administration of chemotherapy
- At least 7 days from prior major surgery
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
- Patient judged to be 'medically stable' by primary investigator.
Who cannot join
- Prior treatment with intrapleural fibrinolytic agents
- Presence of any intracranial mass
- Traumatic hemorrhagic pleural effusion
- Major hemorrhage, coincidental stroke, or major trauma
- High-risk for systemic bleeding
- Allergy or intolerance to dornase alfa
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- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study)
- Expected survival less than six weeks
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Steven B Standiford, MD, 215-537-7400, steven.standiford@ctca-hope.com
Jack Medendorp, 215-537-3160, jack.medendorp@ctca-hope.com
About this study
The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.
- Being tested
- Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)Drug
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Intra-pleural deoxyribonuclease 5mg and intra-pleural Alteplase 10mg, every 12 hours over 72 hours (total of 6 treatments) Receives: Drug: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic improvement in area of pleural collection
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loculated or Non-draining Malignant Pleural EffusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven B Standiford, MD, Principal investigator, Eastern Regional Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135588
- Sponsor's protocol ID
- ERMC 13-29
- Status last verified
- Feb 2021
- First submitted
- 8 May 2014
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Tissue Plasminogen Activator (Tpa) and Dornase Alfa (Dnase) Administration Through Intrapleural Catheters for the Treatment of Loculated or Non-Draining Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT02135588
- Acronym / sponsor ID
- ERMC 13-29
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Eastern Regional Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tPA administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)Intra-pleural deoxyribonuclease 5mg and intra-pleural Alteplase 10mg, every 12 hours over 72 hours (total of 6 treatments) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical failure of small-bore chest tube with persistent pleural effusion
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
- Life expectancy ≥ 6 weeks
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.0 g/dL
Key exclusion criteria (13 listed)
- Prior treatment with intrapleural fibrinolytic agents
- Presence of any intracranial mass
- Traumatic hemorrhagic pleural effusion
- Major hemorrhage, coincidental stroke, or major trauma
- High-risk for systemic bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) | Drug | Active Treatment |
Primary outcome
Radiographic improvement in area of pleural collection
Time frame: Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven B Standiford, MD principal investigator
Eastern Regional Medical Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE) in people with Loculated or Non-draining Malignant Pleural Effusions, run by Eastern Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven B Standiford, MD (215-537-7400, steven.standiford@ctca-hope.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic improvement in area of pleural collection (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.