Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion

NCT ID: NCT04131231

Last Updated: 2019-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2021-06-15

Brief 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 (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.

Conditions

Lung Cancer; Breast Cancer; Malignant Pleural Effusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microparticles packaging methotrexate (MPs-MTX) group

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

Group Type: EXPERIMENTAL

microparticles packaging methotrexate (MPs-MTX)

Intervention Type: DRUG

50ml, intrapleural infusion, day5,6,7,8

recombinant human interleukin-2(rhIL-2) group

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

Group Type: ACTIVE_COMPARATOR

recombinant human interleukin-2(rhIL-2)

Intervention Type: DRUG

50ml, intrapleural infusion, day5,8,11

Interventions

microparticles packaging methotrexate (MPs-MTX)

50ml, intrapleural infusion, day5,6,7,8

Intervention Type: DRUG

recombinant human interleukin-2(rhIL-2)

50ml, intrapleural infusion, day5,8,11

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed as lung cancer or breast cancer;

2. Cytologically or histologically confirmed MPE needing thoracocentesis treatment;

3. Without thoracocentesis treatment within 4 weeks;

4. ECOG PS score: 0-2 points;

5. Predicted life expectancy greater than 3 months;

6. 18 years ≤Age ≤80 years；

7. 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;

8. Hepatic function：alanine aminotransferase(ALT) and aspartate aminotransferase(AST) ≤2.5×ULN，serum total bilirubin≤1.5× ULN;

9. Renal function：blood urea nitrogen(BUN) and serum creatinine(Cr) ≤1.5×ULN, or endogenous creatinine clearance rate(Ccr) ≥60mL/min;

10. Without other severe cardiac disease or respiratory disease;

11. The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.

Exclusion Criteria

1. Inappropriate to receive chemotherapy;

2. Women who are pregnant, preparing to be pregnant, breastfeeding;

3. Known or suspected hypersusceptibility to any agents used in the treatment protocol;

4. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;

5. With severe infection;

6. With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis;

7. With cognitive impairment or low compliance;

8. Participating in other clinical trials within 4 weeks;

9. Undergoing immunotherapy within 3 months;

10. Other conditions considered to be inappropriate to be enrolled by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Fei Ma

Deputy Director of Oncology Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fei Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Science

Central Contacts

Fei Ma, MD

Role: CONTACT

drmafei@126.com

8613910217780

Other Identifiers

NCC20180327

Identifier Type: -

Identifier Source: org_study_id