NAM-Trial: Multiferon in Malignant Melanoma

Exclusion Criteria

• •1. Mucous membrane or ocular melanoma
• •2. Any evidence of distant metastasis (e.g. whole body CT-scan including brain scan within 4 weeks before inclusion)
• •3. Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris).
• •4. ALAT or ASAT \> 2 x ULN
• •5. Total bilirubin \> 2 x ULN
• •6. Creatinine \> 2 x ULN
• •7. Evidence or history of depression. If this condition can not be ruled out, the patient should be transferred to a psychiatrist for consultation and further assessment before inclusion.
• •8. Patients with seizure disorders requiring anticonvulsant therapy
• •9. Any of the following abnormal baseline hematologic/laboratory values:
• •Hb \< 10g/dl WBC \< 3.0x109 /l Platelets \< 100x109 /l
• •10. Presence of active autoimmune disease
• •11. Concurrent systemic glucocorticoids or any other systemic immunosuppressive therapy
• •12. Unwilling or unable to comply with the requirements of the protocol
• •13. Known infection with HBV, HCV, HIV
• •14. Pregnant or lactating women
• •15. Unwillingness or inability to employ an effective barrier method of birth control throughout the study and for up to 3 months after end of treatment in female or male patients
• •16. Known or suspected allergy to human interferon alpha or any ingredient of the IMP.
• •17. Any thyroid dysfunctions not responsive to therapy
• •18. Presence of chronic hepatitis with decompensated liver cirrhosis
• •19. Immunosuppression in patients with transplantation
• •20. Evidence or history of bleeding diathesis or coagulopathy