peg-interferon alfa-2b in treating patients with stage iv melanoma

Conditions: Melanoma (Skin)

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.

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.

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

Keywords: recurrent melanoma stage iv melanoma