Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226408
Status:
UNKNOWN
Last Update Posted:
2006-06-21
First Post:
2005-09-25
Brief Title:
Standard High-Dose Alpha Interferon Versus Intermittent High-Dose Alpha Interferon
Sponsor:
Dermatologic Cooperative Oncology Group
Organization:
Dermatologic Cooperative Oncology Group
Study Overview
Official Title:
Randomized Multicenter Study for Adjuvant Treatment of Stage III Malignant Melanoma Intermittent High-Dose Intravenous Interferon Alpha-2b Versus Standard High-Dose Interferon Alpha-2b Therapy
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
The study protocol is being conducted to compare intermittent high-dose iv administation of interferon alpha-2b with the standard high-dose treatment by Kirkwood with distant metastasis free survival DMFI as a primary endpoint
Detailed Description:
Arm A Interferon-alpha-2b 20 MIUm2 for 4 weeks 5 days a week iv followed by 48 weeks of treatment with 3 x 10 MIUm2 sc Arm B Interferon-alpha-2b 20 MIUm2 for 4 weeks 5 days a week iv repeated 3 times with 12 treatment-free-weeks between the cycles
Secondary endpoints Improved overall survival rate Assess side effects of therapy in both treatment arms Assess time spent on sick leave Assess number of treatment-related days in hospital Assess overall performance status Assess blood MX protein levels
Secondary endpoints Improved overall survival rate Assess side effects of therapy in both treatment arms Assess time spent on sick leave Assess number of treatment-related days in hospital Assess overall performance status Assess blood MX protein levels
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