Vestibular Schwannoma Clinical Trial
— EndostatinOfficial title:
Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping
Verified date | February 2017 |
Source | Beijing Tiantan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 30 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital | Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline in QOL(quality of life) score after every course of the treatment | Patients' QOL(quality of life) would be evaluated after every course of the treatment. | Baseline,Month 3,Month 7,Month 11 | |
Primary | 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 | Change from Baseline in hearing ability after every course of the treatment | Patients' hearing ability would be tested after every course of the treatment. | Baseline,Month 3,Month 7,Month 11 |
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