RATIONALE: 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.

Condition	Treatment or Intervention	Phase
Recurrent Melanoma Stage IV Melanoma	Drug: PEG-interferon alfa-2b  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: cytokine therapy  Procedure: growth factor antagonist therapy  Procedure: interferon therapy	Phase II

Further Study Details: 

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.

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV melanoma, meeting 1 of the following staging criteria:
• Stage M1a or M1b
• Stage M1c with normal lactic dehydrogenase and largest tumor mass less than 3 cm in greatest diameter
• Previously untreated OR recevied up to 2 prior systemic therapy regimens for metastatic disease
• Plasma basic fibroblast growth factor level at least 15 pg/mL
• Measurable or evaluable disease
• No brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• 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)

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• ALT no greater than 2 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No myocardial infarction within the past 6 months

Other

• No 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
• No other concurrent illness that would preclude study participation
• No history of severe depression
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• At least 4 weeks since prior interferon in the adjuvant or metastatic setting

Chemotherapy

• At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting

Endocrine therapy

• At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting

Radiotherapy

• At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting

Surgery

• At least 4 weeks since prior surgery in the adjuvant or metastatic setting

Other

• At least 4 weeks since other prior therapy in the adjuvant or metastatic setting

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Georgia
      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States; Recruiting
      Hinsdale Hematology Oncology Associates, Hinsdale,  Illinois,  60521,  United States; Recruiting
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States; Recruiting
      Swedish-American Regional Cancer Center, Rockford,  Illinois,  61104-2315,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Ohio
      MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland,  Ohio,  44109,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States; Recruiting
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601-5494,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States; Recruiting

Study chairs or principal investigators

Ronald S. Go, MD,  Study Chair,  Gundersen Lutheran Cancer Center   

Study ID Numbers:  CDR0000258114; ECOG-2602; NCT00049530
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049530
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08