PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility Criteria
Inclusion criteria: 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) Alanine Aminotransferase (ALT) no greater than 2 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min At least 4 weeks since prior interferon in the adjuvant or metastatic setting At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting At least 4 weeks since prior surgery in the adjuvant or metastatic setting At least 4 weeks since other prior therapy in the adjuvant or metastatic setting Negative pregnancy test Fertile patients must use effective contraception Exclusion criteria: 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
Sites / Locations
- UAB Comprehensive Cancer Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Eureka Community Hospital
- Galesburg Clinic, PC
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Summa Center for Cancer Care at Akron City Hospital
- Aultman Cancer Center at Aultman Hospital
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- UPMC Cancer Centers
- West Virginia University Health Sciences Center - Charleston
- Gundersen Lutheran Center for Cancer and Blood
Arms of the Study
Arm 1
Experimental
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.