Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005072
Status:
TERMINATED
Last Update Posted:
2014-07-29
First Post:
2000-04-06
Brief Title:
Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
Phase III Study Evaluating the Safety and Efficacy of Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation Therapy Summary Last Updated 022001
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 prostate cancer cells may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy
PURPOSE Phase III trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy
Detailed Description:
OBJECTIVES I Determine the toxicity and tolerability of Leuvectin in patients with locally recurrent organ-confined prostate cancer after radiotherapy II Determine 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 an open-label multicenter study Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14 Patients are re-evaluated at week 10 Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression
ACTUAL ACCRUAL A total of 25 patients were accrued for this study
OUTLINE This is an open-label multicenter study Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14 Patients are re-evaluated at week 10 Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression
ACTUAL ACCRUAL A total of 25 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 |
|---|---|---|---|
| UCLA-9906108 | OTHER | None | None |
| CDR0000067677 | REGISTRY | None | None |
| NCI-G00-1721 | OTHER | NCI | None |