Malignant Pleural EffusionPhase 2NCT02657460
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
A Phase 2 study testing tumor derived microparticles and cisplatin in people with Malignant Pleural Effusion, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- tumor derived microparticles and cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
- The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
- stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
- 18-70 years old;
- normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
- agreed to participate in the study and sign an informed consent;
- without other severe comorbidities.
Who cannot join
- lactating or pregnant patients;
- allergy to multiple drugs;
- with other severe comorbidities or psychological diseases;
- severe infection;
- participation in other clinical trials within the recent three months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430022
Yang Jin, doctor, +86 13554361146, whuhjy@sina.com
About this study
The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.
Read the detailed description
Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.
- Conditions
- Malignant Pleural Effusion
- Being tested
- tumor derived microparticles, cisplatin
- Keywords
- chemotherapy, microparticle, malignant pleural effusion
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor derived microparticlesBiological
The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
cisplatinDrug
Also called cisplatinum
cisplatin is a traditional drug for lung cancer
| Study group | Role | What they receive |
|---|---|---|
| MTX-ATMPs | Experimental | methotrexate-autologous tumor derived microparticles Receives: Biological: tumor derived microparticles |
| cisplatin | Sham comparator | Cisplatin is a traditional treatment for lung cancer Receives: Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleural effusions volume
Measured: four weeks
Secondary outcomes (13)
Rivalta Test of pleural effusions
Measured: four weeks
total protein level of pleural effusions
Measured: four weeks
total karyocytes count of pleural effusions
Measured: four weeks
lactic dehydrogenase level of pleural effusions
Measured: four weeks
adenosine deaminase level of pleural effusions
Measured: four weeks
the cytology test of pleural effusions
Measured: four weeks
Karnofsky index
Measured: four weeks
survival time
Measured: six month
carcino embryonie antigen level in microgramme/L in serum
Measured: four weeks
CYFRA21-1 level in ng/mL in serum
Measured: four weeks
neuron specific annuals level in microgramme/L in serum
Measured: four weeks
squamous cell carcinoma antigen level in ng/mL in serum
Measured: four weeks
carcino embryonie antigen level in microgramme/L in pleural effusions
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Yang Jin, doctor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657460
- Sponsor's protocol ID
- v1.4
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to share IPD now
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT02657460
- Acronym / sponsor ID
- v1.4
- Conditions
- Malignant Pleural Effusion
- Keywords
- chemotherapy, microparticle, malignant pleural effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Jan 2016 (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 study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.
Detailed description
Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-ATMPs | Experimental | Biological: tumor derived microparticlesmethotrexate-autologous tumor derived microparticles |
| cisplatin | Sham comparator | Drug: cisplatinCisplatin is a traditional treatment for lung cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
- The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
- stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
- 18-70 years old;
- normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
Key exclusion criteria (5 listed)
- lactating or pregnant patients;
- allergy to multiple drugs;
- with other severe comorbidities or psychological diseases;
- severe infection;
- participation in other clinical trials within the recent three months.
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 |
|---|---|---|
| tumor derived microparticlesThe main difference between the two treatment groups is the biological coat, which is tumor derived microparticles. | Biological | MTX-ATMPs |
| cisplatinAlso: cisplatinumcisplatin is a traditional drug for lung cancer | Drug | cisplatin |
Primary outcome
Pleural effusions volume
Time frame: four weeks
13 secondary outcomes
Rivalta Test of pleural effusions
Time frame: four weeks
total protein level of pleural effusions
Time frame: four weeks
total karyocytes count of pleural effusions
Time frame: four weeks
lactic dehydrogenase level of pleural effusions
Time frame: four weeks
adenosine deaminase level of pleural effusions
Time frame: four weeks
the cytology test of pleural effusions
Time frame: four weeks
Karnofsky index
Time frame: four weeks
survival time
Time frame: six month
carcino embryonie antigen level in microgramme/L in serum
Time frame: four weeks
CYFRA21-1 level in ng/mL in serum
Time frame: four weeks
neuron specific annuals level in microgramme/L in serum
Time frame: four weeks
squamous cell carcinoma antigen level in ng/mL in serum
Time frame: four weeks
carcino embryonie antigen level in microgramme/L in pleural effusions
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No. no plan to share IPD now
Related trials for Malignant Pleural Effusion
Not yet recruitingObservational study
Union-LC-MPE Cohort:A Multicenter Cohort Study on Diagnosis and Prognosis of Malignant Pleural Effusion in Lung Cance
Malignant Pleural Effusions (Mpe), Lung Cancer (Diagnosis)
RecruitingObservational study
UNC Pleural Fluid Registry
Lung Cancer, Lung Infection
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
RecruitingObservational study
Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions
Pleural Neoplasm
Recruiting
Safety and Feasibility of Medical Thoracoscopy Using Single-use Flexible Bronchoscope Versus SemiRigid Pleuroscope in Pleural Effusion
Malignant Pleural Effusions (Mpe), Medical Thoracoscopy
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.
Yang Jin, doctor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tumor derived microparticles and cisplatin in people with Malignant Pleural Effusion, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 7 inclusion and 5 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 26 Feb 2019. 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 China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Feng Wu, Master (086-13476080943, wufengxiehe@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleural effusions volume (time frame: four weeks). 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 26 Feb 2019.