Ignite Creation Date:
2024-05-06 @ 2:42 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02104323
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2014-03-26
Brief Title:
Endostatin Study for Patients With Neurofibromatosis Type 2 NF2 and NF2-Related Tumors
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Recombinant Human Endostatin Injection Study for Patients With Neurofibromatosis Type 2 NF2 and NF2-Related Tumors by Continuous Intravenous Pumping
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Endostatin
Brief Summary:
1Preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on NF2 2Preliminarily evaluate the safety and the patients tolerance of the treatment of endostatin 3Provide an objective basis for an enlarged randomized double-blind trial
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 emotionaland 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 sizeRecombinant 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 tumors 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
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 sizeRecombinant 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 tumors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ChiCTR-ONRC-14004210 | REGISTRY | Chinese clinical trial registry | None |