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

NCT04131231 | Unknown

• 1 other identifier: NCC20180327
• Study Type: interventional
• Target: 248
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer; Breast Cancer; Malignant Pleural Effusion

Keywords

microparticles packaging chemotherapeutic drugs; MPCD; malignant pleural effusion; MPE

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR）

  Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks

  4 weeks

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  up to 20 months

• Overall Survival(OS)

  up to 20 months

• Level of tumor markers

  up to 20 months

• Index of pleural effusion

  up to 20 months

Study Arms (2)

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

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

Drug: recombinant human interleukin-2(rhIL-2)

Interventions

microparticles packaging methotrexate (MPs-MTX) DRUG

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

microparticles packaging methotrexate (MPs-MTX) group

recombinant human interleukin-2(rhIL-2) DRUG

50ml, intrapleural infusion, day5,8,11

recombinant human interleukin-2(rhIL-2) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years ≤Age ≤80 years；
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pleural Neoplasms; Pleural Effusion; Pleural Diseases

Study Officials

• Fei Ma, MD

  Cancer Hospital Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma, MD

CONTACT

8613910217780; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Oncology Medicine

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: October 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: June 15, 2021
• Last Updated: October 18, 2019

Record last verified: 2019-10