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Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

Primary Purpose

Leptomeningeal Metastasis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Recombinant Human Endostatin
intrathcal methotrexate
Targeted drugs for non-small cell lung cancer
Sponsored by
Hui Bu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastasis focused on measuring Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis

Eligibility Criteria

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

Inclusion Criteria:

  1. Age over 18 years old
  2. Pathologically proven non-small cell lung cancer
  3. Karnofsky performance status ≥ 40
  4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
  5. No severe abnormal liver and kidney function;
  6. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Evidence of bleeding diathesis or serious infection
  2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  3. Pregnant or lactating women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Endostatin Therapy for NSCLC of LM

    Arm Description

    Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .

    Outcomes

    Primary Outcome Measures

    Leptomeningeal Metastasis Overall survival
    Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
    Neurological Progression Free Survival
    From the start of treatment until central nervous system metastase progression or death due to any cause
    The incidence of adverse reactions
    From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)

    Secondary Outcome Measures

    Objective Response Rate
    ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
    Neurological assessment
    In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
    progression-free survival
    Proportion of patients progression-free by investigator assessment per RECIST v1.1
    Overall survival
    defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up

    Full Information

    First Posted
    April 18, 2020
    Last Updated
    May 23, 2020
    Sponsor
    Hui Bu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04356118
    Brief Title
    Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
    Official Title
    Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hui Bu

    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
    The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leptomeningeal Metastasis
    Keywords
    Recombinant Human Endostatin, Non-Small Cell Lung Cancer with Leptomeningeal Metastasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endostatin Therapy for NSCLC of LM
    Arm Type
    Experimental
    Arm Description
    Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant Human Endostatin
    Other Intervention Name(s)
    Endostatin
    Intervention Description
    endostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
    Intervention Type
    Drug
    Intervention Name(s)
    intrathcal methotrexate
    Intervention Description
    Intrathecal chemotherapy specified dose on specified days.
    Intervention Type
    Drug
    Intervention Name(s)
    Targeted drugs for non-small cell lung cancer
    Intervention Description
    EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
    Primary Outcome Measure Information:
    Title
    Leptomeningeal Metastasis Overall survival
    Description
    Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
    Time Frame
    36 months
    Title
    Neurological Progression Free Survival
    Description
    From the start of treatment until central nervous system metastase progression or death due to any cause
    Time Frame
    36 months
    Title
    The incidence of adverse reactions
    Description
    From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate
    Description
    ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
    Time Frame
    36 months
    Title
    Neurological assessment
    Description
    In accordance with the standard of Response Assessment in Neuro-Oncology(RANO) Neurological Assessment group.The maximum value is 29 and the minimum value is 0.The higher scores mean a worse outcome.
    Time Frame
    36 months
    Title
    progression-free survival
    Description
    Proportion of patients progression-free by investigator assessment per RECIST v1.1
    Time Frame
    36 months
    Title
    Overall survival
    Description
    defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age over 18 years old Pathologically proven non-small cell lung cancer Karnofsky performance status ≥ 40 LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI . No severe abnormal liver and kidney function; Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Evidence of bleeding diathesis or serious infection Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) Pregnant or lactating women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Bu
    Phone
    86-13831106903
    Email
    buhuimy1@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hui Bu
    Organizational Affiliation
    The Second Hospital of Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis

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