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

May 23, 2020 updated by: Hui Bu
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endostatin Therapy for NSCLC of LM

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 .
Drug: Recombinant Human Endostatin
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.
Other Names:
  • Endostatin
Drug: intrathcal methotrexate
Intrathecal chemotherapy specified dose on specified days.
Drug: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leptomeningeal Metastasis Overall survival
Time Frame: 36 months
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
36 months
Neurological Progression Free Survival
Time Frame: 36 months
From the start of treatment until central nervous system metastase progression or death due to any cause
36 months
The incidence of adverse reactions
Time Frame: 36 months
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 36 months
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
36 months
Neurological assessment
Time Frame: 36 months
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.
36 months
progression-free survival
Time Frame: 36 months
Proportion of patients progression-free by investigator assessment per RECIST v1.1
36 months
Overall survival
Time Frame: 36 months
defined as time from Non-Small Cell Lung Cancer diagnosis to death due to any cause or last follow-up
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hui Bu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH 005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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