PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
3 other identifiers
interventional
32
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2004
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedStudy Start
First participant enrolled
January 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedJune 29, 2023
June 1, 2023
8.6 years
November 12, 2002
January 30, 2014
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma b-FGF Level Response
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.
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
Secondary Outcomes (3)
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
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
Overall Survival
assessed every 3 months if <2 years, and every 6 months if 2-3 years
Study Arms (1)
PEG-interferon alfa-2b
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Histologically confirmed stage IV melanoma
- Stage M1a, M1b, or M1c
- Mucosal, ocular, or unknown primary melanoma
- Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- Plasma basic fibroblast growth factor level at least 15 pg/mL
- Measurable or evaluable disease
- Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
- Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry
- Age: 18 and over
- ECOG Performance status of 0-2
- Life expectancy at least 6 months
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 8 g/dL (transfusions allowed)
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- +10 more criteria
You may not qualify if:
- Myocardial infarction within the past 6 months
- Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Other concurrent illness that would preclude study participation
- History of severe depression
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, 25304, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- STUDY CHAIR
Ronald S. Go, MD
Gundersen Lutheran Center for Cancer and Blood
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2002
First Posted
January 27, 2003
Study Start
January 13, 2004
Primary Completion
August 1, 2012
Study Completion
June 1, 2014
Last Updated
June 29, 2023
Results First Posted
June 3, 2014
Record last verified: 2023-06