Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003646
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
Status:
COMPLETED
Status Verified Date:
2011-07
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:
RATIONALE Injecting allovectin-7 into a persons melanoma cells may make the body build an immune response that will kill tumor cells
PURPOSE Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment
PURPOSE Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES I Demonstrate an objective clinical response partial or complete with a median duration of at least 4 months in 15 of patients with stage III or IV melanoma treated with Allovectin-7 Allovectin-7 is a direct gene transfer immunotherapeutic agent
II Determine the benefits risks and side effects of Allovectin-7 in this patient population
PROTOCOL OUTLINE This is a multicenter study Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks At week 9 a complete disease status assessment is performed Patients with stable or responding disease may receive additional courses of 6 injections
PROJECTED ACCRUAL
A total of 70 patients will be accrued for this study
II Determine the benefits risks and side effects of Allovectin-7 in this patient population
PROTOCOL OUTLINE This is a multicenter study Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks At week 9 a complete disease status assessment is performed Patients with stable or responding disease may receive additional courses of 6 injections
PROJECTED ACCRUAL
A total of 70 patients will be 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 |
|---|---|---|---|
| VCL-1005-205 | OTHER | Vical | None |