Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040170
Status:
TERMINATED
Last Update Posted:
2006-11-02
First Post:
2002-06-21
Brief Title:
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Sponsor:
Transgene
Organization:
Transgene
Study Overview
Official Title:
Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010MVA-MUC1-IL2 in Patients With Adenocarcinoma of the Prostate
Status:
TERMINATED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves the use of an experimental product TG4010 The purpose of the study is to determine if TG4010 can stimulate the bodys immune system to help it fight the cancer
Detailed Description:
The experimental product TG4010 is a modified vaccinia virus already used in humans into which two 2 genes have been placed One gene is for a protein MUC1 found in cancer cells The second gene is for human interleukin 2 IL2 which the bodys immune system makes to help it fight cancer The TG4010 is given as an injection under the skin subcutaneous once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve 12 weeks If the therapy is working it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated
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