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

This study has been completed.
Sponsor:
Collaborator:
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Li Peng, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT02104323
First received: March 26, 2014
Last updated: February 7, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Vestibular Schwannoma Neurofibromatosis Type 2 Drug: Endostatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping

Resource links provided by NLM:


Further study details as provided by Li Peng, Beijing Tiantan Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: January 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Recombinant Human Endostatin

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.

  Eligibility

Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104323

Locations
China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Beijing Tiantan Hospital
Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
Investigators
Study Director: Pinan Liu Beijing Tiantan Hospital
Principal Investigator: Fu Zhao Beijing Neurosurgical Institute
  More Information

Publications:
Responsible Party: Li Peng, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02104323     History of Changes
Other Study ID Numbers: Tian-drug-neuro001
ChiCTR-ONRC-14004210 ( Registry Identifier: Chinese clinical trial registry )
Study First Received: March 26, 2014
Last Updated: February 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Li Peng, Beijing Tiantan Hospital:
Neurofibromatosis Type 2
Vestibular Schwannoma
Other NF2-related tumors

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurilemmoma
Neuroma, Acoustic
Neurofibromatosis 2
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Cranial Nerve Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms

ClinicalTrials.gov processed this record on August 17, 2017