Lung CancerNCT04131231
Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
A study testing microparticles packaging methotrexate (MPs-MTX) and recombinant human interleukin-2(rhIL-2) in people with Lung Cancer and Breast Cancer, run by Peking Union Medical College.
Trial summary
This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Breast Cancer, Malignant Pleural Effusion
- What is being tested?
- microparticles packaging methotrexate (MPs-MTX) and recombinant human interleukin-2(rhIL-2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 15 Jun 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed as lung cancer or breast cancer;
- Cytologically or histologically confirmed MPE needing thoracocentesis treatment;
- Without thoracocentesis treatment within 4 weeks;
- ECOG PS score: 0-2 points;
- Predicted life expectancy greater than 3 months;
- 18 years ≤Age ≤80 years；
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- Bone marrow function: hemoglobin(HGB) ≥90g/L，white blood cells(WBC) ≥3.0×10^9/L，absolute neutrophil count(ANC) ≥1.5×10^9/L，platelets (PLT) ≥80×10^9/L，international standardized ratio (INR) <1.5;
- Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN，serum total bilirubin≤1.5× ULN;
- Renal function：blood urea nitrogen(BUN) and serum creatinine(Cr) ≤1.5×ULN, or endogenous creatinine clearance rate(Ccr) ≥60mL/min;
- Without other severe cardiac disease or respiratory disease;
- The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.
Who cannot join
- Inappropriate to receive chemotherapy;
- Women who are pregnant, preparing to be pregnant, breastfeeding;
- Known or suspected hypersusceptibility to any agents used in the treatment protocol;
- With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;
- With severe infection;
- With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis;
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- With cognitive impairment or low compliance;
- Participating in other clinical trials within 4 weeks;
- Undergoing immunotherapy within 3 months;
- Other conditions considered to be inappropriate to be enrolled by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion
This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.
Read the detailed description
After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.
- Conditions
- Lung Cancer, Breast Cancer, Malignant Pleural Effusion
- Being tested
- microparticles packaging methotrexate (MPs-MTX), recombinant human interleukin-2(rhIL-2)
- Keywords
- microparticles packaging chemotherapeutic drugs, MPCD, malignant pleural effusion, MPE
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microparticles packaging methotrexate (MPs-MTX)Drug
50ml, intrapleural infusion, day5,6,7,8
recombinant human interleukin-2(rhIL-2)Drug
50ml, intrapleural infusion, day5,8,11
| Study group | Role | What they receive |
|---|---|---|
| microparticles packaging methotrexate (MPs-MTX) group | Experimental | Patients are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed.
MPs-MTX: 5 U of MPs-MTX containing a total dose of more than 25μg of MTX dissolving in 50ml of physiological saline solution Receives: Drug: microparticles packaging methotrexate (MPs-MTX) |
| recombinant human interleukin-2(rhIL-2) group | Active comparator | Patients are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed.
rhIL-2: 2 million IU of rhIL-2 dissolving in 50ml of physiological saline solution Receives: Drug: recombinant human interleukin-2(rhIL-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks
Measured: 4 weeks
Secondary outcomes (4)
Progression Free Survival (PFS)
Time from the date of first receive treatment to the date of first documented progression or date of death from any cause whichever came first
Measured: up to 20 months
Overall Survival(OS)
Time from the date of first receive treatment to the date of death
Measured: up to 20 months
Level of tumor markers
The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment
Measured: up to 20 months
Index of pleural effusion
Routine, biochemistry and cytological examination of pleural effusion
Measured: up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Ma, Peking Union Medical College
- Investigators
- Fei Ma, MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131231
- Sponsor's protocol ID
- NCC20180327
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT04131231
- Acronym / sponsor ID
- NCC20180327
- Conditions
- Lung Cancer, Breast Cancer, Malignant Pleural Effusion
- Keywords
- microparticles packaging chemotherapeutic drugs, MPCD, malignant pleural effusion, MPE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 18 Oct 2019 (actual)
- 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.
This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.
Detailed description
After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microparticles packaging methotrexate (MPs-MTX) group | Experimental | Drug: microparticles packaging methotrexate (MPs-MTX)Patients are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed. MPs-MTX: 5 U of MPs-MTX containing a total dose of more than 25μg of MTX dissolving in 50ml of physiological saline solution |
| recombinant human interleukin-2(rhIL-2) group | Active comparator | Drug: recombinant human interleukin-2(rhIL-2)Patients are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), ORR is assessed. rhIL-2: 2 million IU of rhIL-2 dissolving in 50ml of physiological saline solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed as lung cancer or breast cancer;
- Cytologically or histologically confirmed MPE needing thoracocentesis treatment;
- Without thoracocentesis treatment within 4 weeks;
- ECOG PS score: 0-2 points;
- Predicted life expectancy greater than 3 months;
Key exclusion criteria (10 listed)
- Inappropriate to receive chemotherapy;
- Women who are pregnant, preparing to be pregnant, breastfeeding;
- Known or suspected hypersusceptibility to any agents used in the treatment protocol;
- With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;
- With severe infection;
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 |
|---|---|---|
| microparticles packaging methotrexate (MPs-MTX)50ml, intrapleural infusion, day5,6,7,8 | Drug | microparticles packaging methotrexate (MPs-MTX) group |
| recombinant human interleukin-2(rhIL-2)50ml, intrapleural infusion, day5,8,11 | Drug | recombinant human interleukin-2(rhIL-2) group |
Primary outcome
Objective Response Rate（ORR）
Time frame: 4 weeks
Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 20 months
Overall Survival(OS)
Time frame: up to 20 months
Level of tumor markers
Time frame: up to 20 months
Index of pleural effusion
Time frame: up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Fei Ma, MD principal investigator
Cancer Hospital Chinese Academy of Medical Science
Questions about this trial
What is this clinical trial studying?
A study testing microparticles packaging methotrexate (MPs-MTX) and recombinant human interleukin-2(rhIL-2) in people with Lung Cancer and Breast Cancer, run by Peking Union Medical College.
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 11 inclusion and 10 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Fei Ma, MD (8613910217780, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: 4 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 18 Oct 2019.