Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003647
Status:
COMPLETED
Last Update Posted:
2008-07-25
First Post:
1999-11-01
Brief Title:
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Vical
Organization:
Vical
Study Overview
Official Title:
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2008-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Injecting allovectin-7 into a persons melanoma cells may make the body build an immune response that will kill tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15 in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone
II Determine the benefits risks and side effects of these regimens in this patient population
PROTOCOL OUTLINE This is a randomized multicenter study Patients are stratified according to sex age and spread of disease cutaneous or nodal vs visceral disease Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 1 hour on day 0 Arm II Patients receive treatment as in arm I Patients also receive Allovectin-7 intratumorally on days 3 and 10
Patients with stable or responding disease may receive additional courses every 28 days
Patients are followed every 4 months
PROJECTED ACCRUAL
A total of 280 patients 140 in each arm will be accrued for this study
II Determine the benefits risks and side effects of these regimens in this patient population
PROTOCOL OUTLINE This is a randomized multicenter study Patients are stratified according to sex age and spread of disease cutaneous or nodal vs visceral disease Patients are randomized to one of two treatment arms
Arm I Patients receive dacarbazine IV over 1 hour on day 0 Arm II Patients receive treatment as in arm I Patients also receive Allovectin-7 intratumorally on days 3 and 10
Patients with stable or responding disease may receive additional courses every 28 days
Patients are followed every 4 months
PROJECTED ACCRUAL
A total of 280 patients 140 in each arm 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-1005-301 | None | None | None |