Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072137
Status:
TERMINATED
Last Update Posted:
2014-12-23
First Post:
2003-11-04
Brief Title:
Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF rF-GM-CSF andor Recombinant Fowlpox-TRICOM rF-TRICOM in Patients With Bladder Carcinoma Scheduled for Cystectomy
Status:
TERMINATED
Status Verified Date:
2013-08
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:
This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells Giving a vaccine directly into the bladder before surgery may cause a stronger immune response and keep tumor cells from coming back after surgery
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety of intravesical administration of recombinant fowlpox virus encoding three different costimulatory molecules B71 ICAM-1LFA-3 called TRICOM -rF-TRICOM recombinant fowlpox-TRICOM vaccine andor recombinant fowlpox encoding sargramostim GM-CSF rF-GM-CSF recombinant fowlpox GM-CSF vaccine adjuvant in the treatment of patients with carcinoma of the bladder scheduled for cystectomy
SECONDARY OBJECTIVES
I Determine the kinetics of viral infection and gene function as well as host response to intravesical recombinant fowlpox virus in the treatment of bladder cancer
OUTLINE This is a dose-escalation study Patients are alternately assigned to Arms A and B Once Arms A and B have finished accrual patients are assigned to Arm C
ARM A closed to accrual 102004 Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
ARM B closed to accrual 102004 Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
ARM C Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
In all arms treatment continues in the absence of disease progression or unacceptable toxicity All patients undergo cystectomy 4-6 days following the last intravesical instillation
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 years
I To assess the safety of intravesical administration of recombinant fowlpox virus encoding three different costimulatory molecules B71 ICAM-1LFA-3 called TRICOM -rF-TRICOM recombinant fowlpox-TRICOM vaccine andor recombinant fowlpox encoding sargramostim GM-CSF rF-GM-CSF recombinant fowlpox GM-CSF vaccine adjuvant in the treatment of patients with carcinoma of the bladder scheduled for cystectomy
SECONDARY OBJECTIVES
I Determine the kinetics of viral infection and gene function as well as host response to intravesical recombinant fowlpox virus in the treatment of bladder cancer
OUTLINE This is a dose-escalation study Patients are alternately assigned to Arms A and B Once Arms A and B have finished accrual patients are assigned to Arm C
ARM A closed to accrual 102004 Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
ARM B closed to accrual 102004 Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
ARM C Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses on days 1 8 15 and 22 with the last dose given 4-6 days prior to cystectomy
In all arms treatment continues in the absence of disease progression or unacceptable toxicity All patients undergo cystectomy 4-6 days following the last intravesical instillation
After completion of study treatment patients are followed up every 6 months for 2 years and then annually for 3 years
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 |
|---|---|---|---|
| P30CA072720 | NIH | CTEP | httpsreporternihgovquickSearchP30CA072720 |
| NCI-2009-00020 | REGISTRY | None | None |
| CDR0000335473 | None | None | None |
| 050301 | OTHER | None | None |
| 5585 | OTHER | None | None |
| U01CA132194 | NIH | None | None |