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Vestibular SchwannomaPhase 2EndostatinNCT02104323

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

A Phase 2 study testing Endostatin in people with Vestibular Schwannoma and Neurofibromatosis Type 2, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 30 years
What is being tested?
Endostatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Jan 2014to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Endostatin
Keywords
Neurofibromatosis Type 2, Vestibular Schwannoma, Other NF2-related tumors
Medical subject headings
Neuroma, Acoustic, Neurofibromatosis 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndostatinDrug

    Also called Recombinant Human Endostatin

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

Study groups in NCT02104323
Study groupRoleWhat they receive
Endostatin，treatment effect evaluationExperimentalPatients 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.
Receives: Drug: Endostatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline,Month 3,Month 7,Month 11

Secondary outcomes (1)

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

    Patients' hearing ability would be tested after every course of the treatment.

    Measured: Baseline,Month 3,Month 7,Month 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02104323
Sponsor's protocol ID
Tian-drug-neuro001
Other IDs
ChiCTR-ONRC-14004210
Acronym
Endostatin
Status last verified
Feb 2017
First submitted
26 Mar 2014
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22805104

  • 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.

    PubMed 19587327

  • 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.

    PubMed 23555840

  • 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.

    PubMed 24249803

  • 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.

    PubMed 20150363

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endostatin in people with Vestibular Schwannoma and Neurofibromatosis Type 2, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in volume of tumour after every course of the treatment (time frame: Baseline,Month 3,Month 7,Month 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104323, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.

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