Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma

Inclusion Criteria

• •Histologically documented metastatic melanoma classified as stage IV (AJCC 2002) of cutaneous origin.
• •≥ 18 years of age
• •ECOG performance status of 0 or 1
• •Patients should not have received any systemic treatment for stage IV disease (study = "first-line" treatment).
• •Patients with progressive disease (PD) to stage IV under prior treatment with interferons as well as all patients who have already been treated with Sorafenib should not be included.
• •The following are allowed:
• •adjuvant interferon treatment (without progressive disease during treatment!) or vaccine therapy for resected stage I-III disease
• •palliative surgery or radiotherapy for stage IV disease
• •prior cytokine or chemotherapy treatment for local-regional disease by isolated limb perfusion or intralesional therapy
• •Life expectancy \>6 months.
• •Patients must have measurable disease defined as \>= 1 not pretreated unidimensional measurable lesion \>= 20 mm (conventional techniques) or \>= 10 mm by spiral CT/MRI.
• •Patients must have adequate hematological, renal and liver functions as defined by laboratory values below performed within 14 days prior to study inclusion:
• •absolute neutrophil count (ANC) \> 1.5 x 109/l
• •platelet count \> 100 x 109/l
• •hemoglobin \> 10 g/dl (\> 6.2 mmol/l)
• •serum creatinine \<= 1.5 x upper limit of institutional values
• •total serum bilirubin \<= 1.5x upper limit of institutional values
• •ALAT and ASAT \<= 2.5x upper limit of institutional values (exception: liver metastases)
• •In addition:
• •Patients should not suffer from frequent vomiting or medical conditions which could interfere with oral medication intake.
• •Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
• •Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index \< 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
• •Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
• •Patients should understand the informed consent and will need to sign the consent