Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415454
Status:
TERMINATED
Last Update Posted:
2011-06-23
First Post:
2006-12-21
Brief Title:
Study Combining Suicide Gene Therapy With Chemoradiotherapy in the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Phase I Study Combining Replication-Competent Adenovirus-Mediated Suicide Gene Therapy With Chemoradiotherapy for the Treatment of Non-Metastatic Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this phase I study is to determine the safety of combining replication-competent adenovirus-mediated suicide gene therapy with chemoradiotherapy in patients with non-metastatic pancreatic cancer
Detailed Description:
The objectives of this study are
To determine the toxicity and maximum tolerated dose MTD of the Ad5-yCDmutTKSR39rep-ADP adenovirus in combination with 5-fluorocytosine 5-FC and valganciclovir vGCV prodrug therapy and standard chemoradiation Fifteen to 30 subjects 5 cohorts of 3 - 6 subjects each with non-metastatic unresectable pancreatic cancer will receive a single intratumoral injection of the Ad5-yCDmutTKSR39rep-ADP adenovirus at one of five dose levels 1 x 10e10 vp 3 x 10e10 vp 1 x 10e11 vp 3 x 10e11 vp 1 x 10e12 vp under endoscopic ultrasound EUS-guidance Beginning three days later subjects will receive 3 weeks 15 days of 5-FC and vGCV prodrug therapy concomitant with a 6 week 30 day course of capecitabine chemotherapy and 54 Gy conformal radiotherapy
The primary endpoint is toxicity at 12 weeks Secondary endpoints are 1 tumor radiological response 2 time to disease progression 3 survival 4 persistence of Ad5-yCDmutTKSR39rep-ADP adenoviral DNA in blood 5 infectious Ad5-yCDmutTKSR39rep-ADP adenovirus in blood and 6 HSV-1 TK gene expression in the pancreas
To determine the toxicity and maximum tolerated dose MTD of the Ad5-yCDmutTKSR39rep-ADP adenovirus in combination with 5-fluorocytosine 5-FC and valganciclovir vGCV prodrug therapy and standard chemoradiation Fifteen to 30 subjects 5 cohorts of 3 - 6 subjects each with non-metastatic unresectable pancreatic cancer will receive a single intratumoral injection of the Ad5-yCDmutTKSR39rep-ADP adenovirus at one of five dose levels 1 x 10e10 vp 3 x 10e10 vp 1 x 10e11 vp 3 x 10e11 vp 1 x 10e12 vp under endoscopic ultrasound EUS-guidance Beginning three days later subjects will receive 3 weeks 15 days of 5-FC and vGCV prodrug therapy concomitant with a 6 week 30 day course of capecitabine chemotherapy and 54 Gy conformal radiotherapy
The primary endpoint is toxicity at 12 weeks Secondary endpoints are 1 tumor radiological response 2 time to disease progression 3 survival 4 persistence of Ad5-yCDmutTKSR39rep-ADP adenoviral DNA in blood 5 infectious Ad5-yCDmutTKSR39rep-ADP adenovirus in blood and 6 HSV-1 TK gene expression in the pancreas
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 |
|---|---|---|---|
| P01CA097012 | NIH | None | httpsreporternihgovquickSearchP01CA097012 |