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

Primary Purpose

Lung Cancer, Breast Cancer, Malignant Pleural Effusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
microparticles packaging methotrexate (MPs-MTX)
recombinant human interleukin-2(rhIL-2)
Sponsored by
Peking Union Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring microparticles packaging chemotherapeutic drugs, MPCD, malignant pleural effusion, MPE

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    microparticles packaging methotrexate (MPs-MTX) group

    recombinant human interleukin-2(rhIL-2) group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Objective Response Rate（ORR）
    Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks

    Secondary Outcome Measures

    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
    Overall Survival(OS)
    Time from the date of first receive treatment to the date of death
    Level of tumor markers
    The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment
    Index of pleural effusion
    Routine, biochemistry and cytological examination of pleural effusion

    Full Information

    First Posted
    October 16, 2019
    Last Updated
    October 16, 2019
    Sponsor
    Peking Union Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04131231
    Brief Title
    Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion
    Official Title
    Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2019 (Anticipated)
    Primary Completion Date
    January 15, 2021 (Anticipated)
    Study Completion Date
    June 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Breast Cancer, Malignant Pleural Effusion
    Keywords
    microparticles packaging chemotherapeutic drugs, MPCD, malignant pleural effusion, MPE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    248 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    microparticles packaging methotrexate (MPs-MTX) group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    recombinant human interleukin-2(rhIL-2) group
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    microparticles packaging methotrexate (MPs-MTX)
    Intervention Description
    50ml, intrapleural infusion, day5,6,7,8
    Intervention Type
    Drug
    Intervention Name(s)
    recombinant human interleukin-2(rhIL-2)
    Intervention Description
    50ml, intrapleural infusion, day5,8,11
    Primary Outcome Measure Information:
    Title
    Objective Response Rate（ORR）
    Description
    Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival (PFS)
    Description
    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
    Time Frame
    up to 20 months
    Title
    Overall Survival(OS)
    Description
    Time from the date of first receive treatment to the date of death
    Time Frame
    up to 20 months
    Title
    Level of tumor markers
    Description
    The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment
    Time Frame
    up to 20 months
    Title
    Index of pleural effusion
    Description
    Routine, biochemistry and cytological examination of pleural effusion
    Time Frame
    up to 20 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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； 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fei Ma, MD
    Phone
    8613910217780
    Email
    drmafei@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fei Ma, MD
    Organizational Affiliation
    Cancer Hospital Chinese Academy of Medical Science
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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