Endostatin Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors (Endostatin)
|ClinicalTrials.gov Identifier: NCT02104323|
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vestibular Schwannoma Neurofibromatosis Type 2||Drug: Endostatin||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors by Continuous Intravenous Pumping|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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.
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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104323
|Beijing Tiantan Hospital Affiliated to Capital Medical University|
|Beijing, Beijing, China, 100050|
|Study Director:||Pinan Liu||Beijing Tiantan Hospital|
|Principal Investigator:||Fu Zhao||Beijing Neurosurgical Institute|