Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02263105
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2014-09-28
Brief Title:
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas
Sponsor:
Huashan Hospital
Organization:
Huashan Hospital
Study Overview
Official Title:
Efficacy and Tolerability of Cisplatin Plus Alternating Weekly Temozolomide in Recurrent High-grade Gliomas A Single-arm Prospective Phase II Clinical Study
Status:
COMPLETED
Status Verified Date:
2018-07
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:
None
Brief Summary:
Currently the prognosis of recurrent high-grade gliomas is still dismal with no standard treatment protocol established Cisplatin CDDP recommended by National Comprehensive Cancer Network NCCN as a chemotherapeutic agent in salvage treatment for recurrent high-grade gliomas was shown to reduce O6-alkylguanine DNA-alkyl transferase AGAT activity and potentially capable of enhancing the antitumor effects of temozolomide TMZ Compared to the standard 5-day TMZ regimen alternating weekly regimen that deliver more prolonged exposure of TMZ may lead to higher cumulative doses and may deplete more O6-methylguanine DNA methyltransferase MGMT thus reducing the resistance of tumor cells to TMZ
The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent high-grade gliomas
The investigators therefore initiate a single-arm Phase II study to evaluate the efficacy and tolerability of CDDP plus alternating weekly TMZ regimen in patients with recurrent high-grade gliomas
Detailed Description:
None
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 |
|---|---|---|---|
| Huashan H | OTHER | Huashan H | None |