Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003167
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Advanced Bladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Intravesical Ad-p53 Treatment in Locally Advanced and Metastatic Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of gene therapy in treating patients with advanced bladder cancer Inserting the p53 gene into a persons bladder cancer cells may improve the bodys ability to fight cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and toxicity of adenovirus p53 Ad-p53 gene therapy in patients with locally advanced or metastatic bladder cancer
II Measure infection with Ad-p53 and confirm expression of p53 after infection
III Characterize clinical response of measurable tumor in these patients IV Determine the duration of effect of this treatment in these patients V Define the time course of elimination of vector from urinary bladder
OUTLINE This is a dose escalation study
Group 1 patients receive adenovirus p53 Ad-p53 intravesically on days 1 and 4 Treatment continues every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients in group 1 receive escalating doses of Ad-p53 In the absence of grade 3 or worse toxicity in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of Ad-p53 on the same schedule If 1 of 3 patients experiences grade 3 toxicity an additional 3 patients are treated at that dose level and dose escalation continues If 1 of 3 patients experience grade 4 toxicity or 2 of 3 patients experience grade 3 toxicity dose escalation ceases and the MTD is defined as the previous dose level Group 2 patients receive Ad-p53 at the MTD on days 1-4 and group 3 patients receive Ad-p53 at the MTD on days 1-4 and 8-11
Patients are followed on day 28 then every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study 3-12 patients for group 1 3-6 patients for group 2 and 6 patients for group 3
I Determine the safety and toxicity of adenovirus p53 Ad-p53 gene therapy in patients with locally advanced or metastatic bladder cancer
II Measure infection with Ad-p53 and confirm expression of p53 after infection
III Characterize clinical response of measurable tumor in these patients IV Determine the duration of effect of this treatment in these patients V Define the time course of elimination of vector from urinary bladder
OUTLINE This is a dose escalation study
Group 1 patients receive adenovirus p53 Ad-p53 intravesically on days 1 and 4 Treatment continues every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients in group 1 receive escalating doses of Ad-p53 In the absence of grade 3 or worse toxicity in the first 3 patients treated subsequent cohorts of 3 patients each receive escalating doses of Ad-p53 on the same schedule If 1 of 3 patients experiences grade 3 toxicity an additional 3 patients are treated at that dose level and dose escalation continues If 1 of 3 patients experience grade 4 toxicity or 2 of 3 patients experience grade 3 toxicity dose escalation ceases and the MTD is defined as the previous dose level Group 2 patients receive Ad-p53 at the MTD on days 1-4 and group 3 patients receive Ad-p53 at the MTD on days 1-4 and 8-11
Patients are followed on day 28 then every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study 3-12 patients for group 1 3-6 patients for group 2 and 6 patients for group 3
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 |
|---|---|---|---|
| CDR0000065968 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA076233 |
| MDA-DM-96172 | None | None | None |
| R21CA076233 | NIH | None | None |