NCT02104323

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

March 26, 2014

Last Update Submit

February 7, 2017

Conditions

Vestibular SchwannomaNeurofibromatosis Type 2

Keywords

Neurofibromatosis Type 2Vestibular SchwannomaOther NF2-related tumors

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in volume of tumour after every course of the treatment

    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 Outcomes (1)

  • Change from Baseline in hearing ability after every course of the treatment

    Baseline,Month 3,Month 7,Month 11

Other Outcomes (1)

  • Change from baseline in QOL(quality of life) score after every course of the treatment

    Baseline,Month 3,Month 7,Month 11

Study Arms (1)

Endostatin，treatment effect evaluation

EXPERIMENTAL

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

Interventions

EndostatinDRUG

Method of drug administration:continuous intravenous pumping; Dosage: 7.5mg/m2/d; Course of treatment: 3 months;Total three treatment courses.

Also known as: Recombinant Human Endostatin
Endostatin，treatment effect evaluation

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (5)

  • Plotkin SR, Merker VL, Halpin C, Jennings D, McKenna MJ, Harris GJ, Barker FG 2nd. Bevacizumab for progressive vestibular schwannoma in neurofibromatosis type 2: a retrospective review of 31 patients. Otol Neurotol. 2012 Aug;33(6):1046-52. doi: 10.1097/MAO.0b013e31825e73f5.

    PMID: 22805104BACKGROUND

  • Plotkin SR, Stemmer-Rachamimov AO, Barker FG 2nd, Halpin C, Padera TP, Tyrrell A, Sorensen AG, Jain RK, di Tomaso E. Hearing improvement after bevacizumab in patients with neurofibromatosis type 2. N Engl J Med. 2009 Jul 23;361(4):358-67. doi: 10.1056/NEJMoa0902579. Epub 2009 Jul 8.

    PMID: 19587327BACKGROUND

  • Nunes FP, Merker VL, Jennings D, Caruso PA, di Tomaso E, Muzikansky A, Barker FG 2nd, Stemmer-Rachamimov A, Plotkin SR. Bevacizumab treatment for meningiomas in NF2: a retrospective analysis of 15 patients. PLoS One. 2013;8(3):e59941. doi: 10.1371/journal.pone.0059941. Epub 2013 Mar 21.

    PMID: 23555840BACKGROUND

  • Plotkin SR, Ardern-Holmes SL, Barker FG 2nd, Blakeley JO, Evans DG, Ferner RE, Hadlock TA, Halpin C; REiNS International Collaboration. Hearing and facial function outcomes for neurofibromatosis 2 clinical trials. Neurology. 2013 Nov 19;81(21 Suppl 1):S25-32. doi: 10.1212/01.wnl.0000435746.02780.f6.

    PMID: 24249803BACKGROUND

  • Mautner VF, Nguyen R, Kutta H, Fuensterer C, Bokemeyer C, Hagel C, Friedrich RE, Panse J. Bevacizumab induces regression of vestibular schwannomas in patients with neurofibromatosis type 2. Neuro Oncol. 2010 Jan;12(1):14-8. doi: 10.1093/neuonc/nop010. Epub 2009 Oct 20.

    PMID: 20150363BACKGROUND

MeSH Terms

Conditions

Neuroma, AcousticNeurofibromatosis 2

Interventions

Endostatins

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesNeurofibromatosesNeurofibromaNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Pinan Liu

    Beijing Tiantan Hospital

    STUDY DIRECTOR

  • Fu Zhao

    Beijing Neurosurgical Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Li Peng

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 4, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

CN(1)