Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026520
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-11-09
Brief Title:
Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma Phase II
Status:
COMPLETED
Status Verified Date:
2003-04
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 and slow the growth of the tumor Thalidomide may stop the growth of cancer by stopping blood flow to the tumor Combining interferon alfa with thalidomide may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide
Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen
Determine the quantitative and qualitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses after documentation of CR
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide
Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen
Determine the quantitative and qualitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses after documentation of CR
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 35 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 |
|---|---|---|---|
| SWOG-S0026 | None | None | None |