A Phase I/II Study to Assess the Safety and Efficacy of Vaccinations With Allogeneic Dendritic Cells: Autologous Tumor-Derived Cells Subjected to Electrofusions in Patients With AJCC Stage IV Renal Cell Carcinoma

Inclusion Criteria

• •The patient must be \_\> 18 years of age
• •The patient must be diagnosed with AJCC stage IV (primary or relasped) RCC
• •The patient must have a baseline Eastern Cooperative Oncology Group (ECOG) Clinical performance of 0-1
• •The patient must have accessible tumor (minimum of 2.5cm in diameter in aggregate and accessible) for vaccine production
• •The patient must have measurable tumor lesions (using Response Evaluation Criteria in Solid Tumors (RECIST) following resection of tumor lesions(s) used for vaccine production. If the patient has received previous radiation or intra-tumoral investigational treatments, the measurable disease must be outside the previous radiation port or treatment area unless there is documented tumor progression following the completion of therapy.
• •The patient must have adequate hematologic, hepatic, and renal function parameters within 21 days prior to the first vaccination (day 0 of treatment):
• •* White blood cell(WBC) count \>\_ 3,000 cell/mm3
• •* Platelet count \>\_ 100,000 platelets/mm3
• •* Creatine(serum) \<2.0mg/dL
• •* Total bilirubin \<2.0 mg/dL
• •* Serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) \<2.0 x Upper limits of normal
• •* Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) \< 2.0 x Upper limits of normal
• •The patient must be serologically negative for human immunodeficiency virus (HIV)-1, HIV-2, and human T lymphotropic virus (HTLV)-1
• •Female patients of childbearing potential must have negative pregnancy tests, refrain from nursing and must agree ton use appropriate contraception for the duration of the trial
• •The patient must have signed and dated written informed consent prior to any study procedures. The consent process must be documented in the patient's medical record