PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Biological: PEG-interferon alfa-2b
- Registration Number
- NCT00049530
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-interferon alfa-2b PEG-interferon alfa-2b 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.
- Primary Outcome Measures
Name Time Method Plasma b-FGF Level Response assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
- Secondary Outcome Measures
Name Time Method Non-progression Rate (Clinical Response to Peginterferon Alfa-2b) assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.
Non-progression rate = CR + PR + SD.Progression Free Survival assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.
Overall Survival assessed every 3 months if <2 years, and every 6 months if 2-3 years Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.
Trial Locations
- Locations (32)
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Swedish-American Regional Cancer Center
🇺🇸Rockford, Illinois, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
West Virginia University Health Sciences Center - Charleston
🇺🇸Charleston, West Virginia, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Graham Hospital
🇺🇸Canton, Illinois, United States