Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003641
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
1999-11-01
Brief Title:
High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0 T3a-bN0 T4a-bN0 and T1-4 N1a2a Microscopic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 Interferon alfa may interfere with the growth of cancer cells It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically
PURPOSE This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery
PURPOSE This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery
Detailed Description:
OBJECTIVES
Primary Objective
Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma
Secondary Objectives
Compare the effect of this treatment regimen on overall survival of these patients
Assess the toxicity of this treatment in these patients
Compare the effect of treatment on quality of life
OUTLINE This is a randomized study Patients are stratified by pathologic lymph node status known vs unknownlymph node staging proceduressentinel lymph node procedure vs elective lymph node dissection vs no lymphadenectomy Breslow depth 10 mm vs 101-20 mm vs 201-40 mm vs 40 mm ulceration of the primary lesion yes vs no vs unknown and disease stage lymph node positive N1 N2a vs lymph node negative N0 Patients are randomized into one of two treatment arms in a 11 ratio
Arm I observation Patients undergo observation for 4 weeks
Arm II Interferon Alfa-2b Patients receive high-dose interferon alfa-2b intravenously IV over 20 minutes daily for 5 consecutive days Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity
Quality of life is assessed before treatment at day 22 every 3 months for 2 years and then every 6 months for 3 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter until 15 years after randomization
PROJECTED ACCRUAL A total of 1420 patients will be accrued for this study over 5 years
Primary Objective
Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma
Secondary Objectives
Compare the effect of this treatment regimen on overall survival of these patients
Assess the toxicity of this treatment in these patients
Compare the effect of treatment on quality of life
OUTLINE This is a randomized study Patients are stratified by pathologic lymph node status known vs unknownlymph node staging proceduressentinel lymph node procedure vs elective lymph node dissection vs no lymphadenectomy Breslow depth 10 mm vs 101-20 mm vs 201-40 mm vs 40 mm ulceration of the primary lesion yes vs no vs unknown and disease stage lymph node positive N1 N2a vs lymph node negative N0 Patients are randomized into one of two treatment arms in a 11 ratio
Arm I observation Patients undergo observation for 4 weeks
Arm II Interferon Alfa-2b Patients receive high-dose interferon alfa-2b intravenously IV over 20 minutes daily for 5 consecutive days Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity
Quality of life is assessed before treatment at day 22 every 3 months for 2 years and then every 6 months for 3 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter until 15 years after randomization
PROJECTED ACCRUAL A total of 1420 patients will be accrued for this study over 5 years
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 |
|---|---|---|---|
| CDR0000066727 | REGISTRY | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA023318 |
| E1697 | OTHER | None | None |
| U10CA023318 | NIH | None | None |