Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors (Endostatin)

February 7, 2017 updated by: Li Peng, Beijing Tiantan Hospital

Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping

1)Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2; 2)Preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)Provide an objective basis for an enlarged randomized double-blind trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Neurofibromatosis type 2 (NF2) is a hereditary tumor predisposition syndrome caused by mutations in the NF2 tumor suppressor gene. Individuals with NF2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. The hallmark of NF2 is bilateral vestibular schwannomas. Historically, most NF2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. Effective treatments are urgently needed for NF2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression.

Previous studies of NF2 patients treated with bevacizumab suggested that inhibition of vascular endothelial growth factor (VEGF) could result in hearing improvement and reduction in tumor size.Recombinant human endostatin can inhibit the formation of blood vessels by inhibiting the migration of vascular endothelial cells .In this way, endostatin can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. In vitro tests, endostatin can inhibit the cell migration and Tube formation of the microvascular endothelial cell line HHEC. Besides, it can inhibit blood vessels' formation of the chicken embryo sac membrane. Based on these studies, we perform this clinical trial to known the treatment effect and tolerability of endostatin on NF2.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital Affiliated to Capital Medical University

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

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1)Patients must be at the age of 16-30
  • 2)Patients must meet the diagnostic criteria for NF2, with bilateral acoustic neuroma and other central nervous system tumors
  • 3)Patients must not be treated with other drugs or radiation therapy recently
  • 4)Patients should live in Beijing or nearby and can be treated in hospital
  • 5)Patients must be healthy and not be seriously allergic with biological agents
  • 6)Patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent.

Exclusion Criteria:

  • 1)Treated with other drugs, surgery or radiation therapy recently
  • 2)Brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time
  • 3)Being pregnant or try to get pregnant, lactating women
  • 4)With acute or chronic infectious diseases
  • 5)With heart diseases, cardiac dysfunction or abnormal ECG
  • 6)With uncontrolled neural or mental diseases, poor compliance
  • 7)Not available for enhanced MRI
  • 8)Take part in any other clinical trial
  • 9)With other conditions that are considered not suitable for this clinical trial.

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，treatment effect evaluation
Patients receive continuous intravenous Endostatin drug pumping during the course of treatment. The drug dosage is 7.5mg/m2/d. Every course of treatment lasts three months. Patients are designed to receive total three courses of treatment if there is no disease progression. The interval between two courses is one month.
Drug: Endostatin
Method of drug administration:continuous intravenous pumping; Dosage: 7.5mg/m2/d; Course of treatment: 3 months;Total three treatment courses.
Other Names:
  • Recombinant Human Endostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in volume of tumour after every course of the treatment
Time Frame: Baseline,Month 3,Month 7,Month 11
Patients in this clinical trial would receive MRI test to evaluate the volume of tumour after every course of the treatment.
Baseline,Month 3,Month 7,Month 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in hearing ability after every course of the treatment
Time Frame: Baseline,Month 3,Month 7,Month 11
Patients' hearing ability would be tested after every course of the treatment.
Baseline,Month 3,Month 7,Month 11

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in QOL(quality of life) score after every course of the treatment
Time Frame: Baseline,Month 3,Month 7,Month 11
Patients' QOL(quality of life) would be evaluated after every course of the treatment.
Baseline,Month 3,Month 7,Month 11

Collaborators and Investigators

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

Sponsor

Beijing Tiantan Hospital

Collaborators

Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tian-drug-neuro001
  • ChiCTR-ONRC-14004210 (Registry Identifier: Chinese clinical trial registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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