Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01956734
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2013-09-27
Brief Title:
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Phase I Trial of Combination of DNX-2401 Formerly Named Delta-24-RGD Oncolytic Adenovirus With a Short Course of Temozolomide for Treatment of Glioblastoma at First Recurrent
Status:
COMPLETED
Status Verified Date:
2017-06
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:
D24GBM
Brief Summary:
Phase I trial unicentric uncontrolled Intratumoral injection or intramural into the resected tumor cavity of DNX2401 into brain tissue will be followed by up to two 28 - day cycles of oral temozolomide TMZ in schedule of 7 days on7 days off to evaluate safety of the combination Completion of two full cycles of TMZ will be dependent upon tolerance and toxicity
The rationale in using the virus with chemotherapy begins with the lessons learned in many clinical trials in glioblastoma GBM about both the great difficulty of treating this disease with monotherapy and the limitations of the therapeutic virus The best clinical results in recent years have been achieved with combinations of multiple therapeutics efforts including maximum resection and chemotherapy immunotherapy and targeted therapies
There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our trial design The dose-dense schemes of TMZ like the one we will use have been developed with the aim to saturate o6-methylguanine-DNA-methyltransferase MGMT The published results to date have shown reasonable toxicity albeit with modest efficacy these schemes are now in phase III trials In addition autophagy triggered by TMZ could help viral replication in the tumor cells 11
The last argument in favor of this virus TMZ combination is the proved efficacy in killing GBM tumor stem cells In vitro and animals models have shown this combination is much more effective that any of the treatments alone against GBM stem cells and the tumors derived from them
The rationale in using the virus with chemotherapy begins with the lessons learned in many clinical trials in glioblastoma GBM about both the great difficulty of treating this disease with monotherapy and the limitations of the therapeutic virus The best clinical results in recent years have been achieved with combinations of multiple therapeutics efforts including maximum resection and chemotherapy immunotherapy and targeted therapies
There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our trial design The dose-dense schemes of TMZ like the one we will use have been developed with the aim to saturate o6-methylguanine-DNA-methyltransferase MGMT The published results to date have shown reasonable toxicity albeit with modest efficacy these schemes are now in phase III trials In addition autophagy triggered by TMZ could help viral replication in the tumor cells 11
The last argument in favor of this virus TMZ combination is the proved efficacy in killing GBM tumor stem cells In vitro and animals models have shown this combination is much more effective that any of the treatments alone against GBM stem cells and the tumors derived from them
Detailed Description:
DNX2401 will be injected after stereotactic biopsy reveals intraoperative pathology confirming the presence of recurrent glioblastoma The injection will be either intratumoral or intramural with injections throughout the post-resection cavity
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