| Exclusion Criteria: | 1) Pregnant or lactating women.
2) Patients with prior history of another malignancy or concurrent malignancy, except for the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies if the patient is disease free >3 years.
3) Patients with history of ischemic retinopathy.
4) Patients with history of severe cardiac disease: NYHA Functional Class III or IV, myocardial infarction within 6 months, uncontrolled ventricular tachyarrythmias or unstable angina.
5) Patients with history of medically significant psychiatric disease if not controlled, especially endogenous depression (does not include reactive depression post-cancer diagnosis), psychosis and bipolar disease.
6) Patients with seizure disorders requiring anticonvulsant therapy.
7) Patients with known infection with HBV, HIV, or other active systemic infection.
8) Patients with known autoimmune disease except for rheumatoid arthritis.
9) Patients with renal disease on hemodialysis.
10) Patients taking continuous or chronic high-dose systemic steroids; if discontinued, there must be a minimum washout period of one month before study drug is begun.
11) Patients with known hypersensitivity to PEG-IFN alpha-2a or its components. |