Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

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

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.

Detailed description: 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: 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

Relevance to patient case: not relevant