Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02934256
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2016-10-13
Brief Title:
Icotinib Study for Patients With Neurofibromatosis Type 2 NF2 and NF2-Related Tumors
Sponsor:
Li Peng
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Icotinib Hydrochloride Tablets Study for Patients With Neurofibromatosis Type 2 NF2 and NF2-Related Tumors
Status:
COMPLETED
Status Verified Date:
2021-09
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:
Icotinib
Brief Summary:
1Preliminarily evaluate the treatment effect of Icotinib Hydrochloride Tablets on NF2 2Preliminarily evaluate the safety and the patients tolerance of the treatment of Icotinib 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 Erlotinib suggested that inhibition of epidermal growth factor receptor EGFR could result in hearing improvement and reduction in tumor size
Much evidence implicates human epidermal growth factor HER receptors in vestibular schwannoma growthSome studies have demonstrated that Merlin the NF2 gene protein product controls surface availability of the EGFR ErbB2 and ErbB3 receptors in human and Drosophila models Besides cell culture models of mouse embryo fibroblasts MEFs support the role of EGFR in NF2-associated tumorigenesis Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures This effect appears to be mediated by EGFR signaling Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas In this way Icotinib can inhibit the nutrition of the tumor and decrease the tumors growth and metastasis Based on these studies we perform this clinical trial to known the treatment effect and tolerability of Icotinib on NF2
Previous studies of NF2 patients treated with Erlotinib suggested that inhibition of epidermal growth factor receptor EGFR could result in hearing improvement and reduction in tumor size
Much evidence implicates human epidermal growth factor HER receptors in vestibular schwannoma growthSome studies have demonstrated that Merlin the NF2 gene protein product controls surface availability of the EGFR ErbB2 and ErbB3 receptors in human and Drosophila models Besides cell culture models of mouse embryo fibroblasts MEFs support the role of EGFR in NF2-associated tumorigenesis Nf2-deficient cells in culture lack contact-dependent inhibition of growth and continue to grow in confluent cultures This effect appears to be mediated by EGFR signaling Treatment of Nf2-deficient cells with EGFR inhibitors such as gefitinib can restore contact-dependent inhibition suggesting that this class of drugs might be useful for NF2 patients with progressive vestibular schwannomas In this way Icotinib can inhibit the nutrition of the tumor and decrease the tumors growth and metastasis Based on these studies we perform this clinical trial to known the treatment effect and tolerability of Icotinib 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