Ignite Creation Date:
2024-05-05 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00669136
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
2008-04-25
Brief Title:
Immunization With AFP GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
Sponsor:
Lisa H Butterfield PhD
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase III Trial Testing Immunization With AFP GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual and limited target patient population for future accrual Did not complete the Phase 1 portion of the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety toxicity and immunological effects of adjuvant administration of an experimental therapy consisting on priming with three intramuscular administrations of a plasmid expressing human AFP phAFP together with a plasmid expressing human GM-CSF phGM-CSF followed by a single intramuscular boost with an AFP adenoviral vector AdVhAFP to patients with locoregionally pre-treated hepatocellular carcinoma HCC
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 |
|---|---|---|---|
| R01CA104524 | NIH | None | httpsreporternihgovquickSearchR01CA104524 |