Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049530
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2002-11-12
Brief Title:
PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
Status:
COMPLETED
Status Verified Date:
2023-06
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 Peginterferon PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor b-FGF levels to normal in patients with metastatic melanoma over-expressing b-FGF
Determine the antitumor effect of this drug in terms of progression-free and overall survival and tumor response in these patients
Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients
Determine the safety profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive PEG-interferon alfa-2b subcutaneously SC once weekly Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached If there is disease progression patients then discontinue treatment If there is no disease progression patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 2 years
Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor b-FGF levels to normal in patients with metastatic melanoma over-expressing b-FGF
Determine the antitumor effect of this drug in terms of progression-free and overall survival and tumor response in these patients
Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients
Determine the safety profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive PEG-interferon alfa-2b subcutaneously SC once weekly Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached If there is disease progression patients then discontinue treatment If there is no disease progression patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| E2602 | OTHER | None | None |