Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
- 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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Suppression of plasma basic fibroblast growth factor (b-FGF) level as measured by ELISA every 3-6 weeks
Ronald S. Go, MD
Gundersen Lutheran Center for Cancer and Blood
United States: Federal Government
|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|