Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002892
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II Stage III or Recurrent Melanoma
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA
Status:
COMPLETED
Status Verified Date:
2007-05
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 the cancer cells It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II stage III or recurrent melanoma
PURPOSE Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II stage III or recurrent melanoma
Detailed Description:
OBJECTIVES I Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence II Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival III Describe the toxic effects of this treatment IV Evaluate the economic implications of implementing effective interferon therapy in these patients
OUTLINE This is a randomized study Patients will be stratified by age sex disease status at entry and participating institution Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years or until disease progression or toxicity intervenes Patients are followed monthly for 6 months quarterly for 18 months and every 6 months thereafter
PROJECTED ACCRUAL A total of 1000 patients will be entered over 5 years
OUTLINE This is a randomized study Patients will be stratified by age sex disease status at entry and participating institution Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years or until disease progression or toxicity intervenes Patients are followed monthly for 6 months quarterly for 18 months and every 6 months thereafter
PROJECTED ACCRUAL A total of 1000 patients will be entered 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 |
|---|---|---|---|
| UKCCCR-AIM-HIGH | None | None | None |
| NCRI-AIM-HIGH | None | None | None |
| EU-96052 | None | None | None |