Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004050
Status:
TERMINATED
Last Update Posted:
2014-07-29
First Post:
1999-12-10
Brief Title:
Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
Phase II Study Evaluating the Safety and Efficacy of Neoadjuvant Leuvectin Immunotherapy for the Treatment of Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Development in prostate cancer indication halted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting the gene for interleukin-2 into a persons cancer cells may improve the bodys ability to fight cancer Using Leuvectin to deliver this gene may be an effective treatment for prostate cancer
PURPOSE Phase II trial to study the effectiveness of Leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer
PURPOSE Phase II trial to study the effectiveness of Leuvectin followed by surgery in treating patients who have stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Assess the toxicity and tolerability of neoadjuvant Leuvectin in patients with stage II or III prostate cancer
Evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population
OUTLINE This is a multicenter study
Patients receive Leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7 Between days 8 and 14 patients undergo retropubic prostatectomy
All patients are followed at 2 months Patients with a PSA no greater than 02 ngmL are followed at 4 months and 6 months every 3 months for 12 months and then every 6 months for 35 years in the absence of disease progression or biochemical failure
ACTUAL ACCRUAL 13 patients were accrued for this study
Assess the toxicity and tolerability of neoadjuvant Leuvectin in patients with stage II or III prostate cancer
Evaluate the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population
OUTLINE This is a multicenter study
Patients receive Leuvectin intraprostatically over 10-30 seconds under ultrasound guidance on day 0 followed by a second injection between days 4 and 7 Between days 8 and 14 patients undergo retropubic prostatectomy
All patients are followed at 2 months Patients with a PSA no greater than 02 ngmL are followed at 4 months and 6 months every 3 months for 12 months and then every 6 months for 35 years in the absence of disease progression or biochemical failure
ACTUAL ACCRUAL 13 patients were accrued for this study
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 |
|---|---|---|---|
| NCI-G99-1568 | OTHER | NCI | None |
| UCLA-9901077-03B | OTHER | None | None |
| CDR0000067244 | REGISTRY | None | None |