Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
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.
- Induction: 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 no disease progression, patients
then proceed to maintenance.
- Maintenance: 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks
No
Ronald S. Go, MD
Study Chair
Gundersen Lutheran Center for Cancer and Blood
United States: Federal Government
CDR0000258114
NCT00049530
September 2003
Name | Location |
---|---|
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
UAB Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |