Comparison Study of Dendritic Cell Vaccine With and Without Cyclophosphamide to Treat Stage IV Melanoma Patients

Exclusion Criteria

• •1. Patients who have received \> 8 cycles of cytotoxic chemotherapy or metastatic melanoma
• •2. Patients who have received any chemotherapy \< 4 weeks before the beginning of the trial
• •3. Patients who have received interferon alpha (IFNα-2b) or sargramostim (GM-CSF) \< 4 weeks before the beginning of the trial
• •4. Patients who have received high-dose interleukin-2 (IL-2) \< 4 weeks before the beginning of the trial
• •5. Patients that have been diagnosed with more than 3 CNS melanoma lesions.
• •6. Patients that have been diagnosed with more than 5 hepatic metastases or any hepatic metastasis \> 5 cm.
• •7. Baseline serum LDH \> 1.1 times the upper limit of normal
• •8. Patients who are HIV+ (HIV patients are often profoundly immunodeficient because of the viral infection and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. Furthermore, the safety of collecting DCs, loading them with antigen and re-infusing these cells to HIV+ patients has not yet been determined.)
• •9. Pregnancy (Pregnancy is associated with considerable immunosuppression 70 and this additional parameter will interfere with the evaluation of DC induced immune responses in melanoma patients. In addition, the safety and tolerability of cell body-loaded DC given subcutaneously is entirely unknown.)
• •10. Patients who have received corticosteroids or other immunosuppressive agents \< 4 weeks before beginning the trial
• •11. Patients with active asthma and/or on treatment for asthma
• •12. Patients with angina pectoris
• •13. Patients with congestive heart failure
• •14. Patients with a history of autoimmune disease including lupus erythematosus, rheumatoid arthritis or thyroiditis
• •15. Patients with active infections including viral hepatitis
• •16. Patients with a history of neoplastic disease other than melanoma \< 5 years prior to entry on the trial except for patients with carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin. Patients who have any of these two types of cancer and melanoma can be included.