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

Completed · Phase 2

Conditions studied: Melanoma (Skin)

In brief

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.

Key facts

Study ID

NCT00049530

Run by

Eastern Cooperative Oncology Group

People needed

32

Starts

2004-01-13

Expected to finish

2014-06-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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

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

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
• Lakeland Regional Cancer Center at Lakeland Regional Medical Center — Lakeland, Florida, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hinsdale Hematology Oncology Associates — Hinsdale, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• Proctor Hospital — Peoria, Illinois, United States
• CCOP - Illinois Oncology Research Association — Peoria, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Peoria — Peoria, Illinois, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Illinois Valley Community Hospital — Peru, Illinois, United States
• Perry Memorial Hospital — Princeton, Illinois, United States
• Swedish-American Regional Cancer Center — Rockford, Illinois, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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