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

NCT04356118 | Unknown Phase 4

• 1 other identifier: BH 005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Leptomeningeal Metastasis

Keywords

Recombinant Human Endostatin; Non-Small Cell Lung Cancer with Leptomeningeal Metastasis

Outcome Measures

Primary Outcomes (3)

• Leptomeningeal Metastasis Overall survival

  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

  From the start of treatment until central nervous system metastase progression or death due to any cause

  36 months

• 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)

  36 months

Secondary Outcomes (4)

• Objective Response Rate

  36 months

• Neurological assessment

  36 months

• progression-free survival

  36 months

• Overall survival

  36 months

Study Arms (1)

Endostatin Therapy for NSCLC of LM

EXPERIMENTAL

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; Drug: intrathcal methotrexate; Drug: Targeted drugs for non-small cell lung cancer

Interventions

Recombinant Human Endostatin DRUG

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.

Also known as: Endostatin

Endostatin Therapy for NSCLC of LM

intrathcal methotrexate DRUG

Intrathecal chemotherapy specified dose on specified days.

Endostatin Therapy for NSCLC of LM

Targeted drugs for non-small cell lung cancer DRUG

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 .

Endostatin Therapy for NSCLC of LM

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hui Bu: lead

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

Endostatins

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Hui Bu

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Bu

CONTACT

86-13831106903; buhuimy1@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 22, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 27, 2020

Record last verified: 2020-05