DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC

Inclusion Criteria

• Histologically confirmed metastatic renal cell carcinoma with measurable disease.
• Tumor tissue available and properly stored for lysate preparation.
• Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.
• Karnofsky Performance Status ≥60%
• Life expectancy ≥ twelve weeks
• Adequate end organ function:
• Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl
• Liver: AST 2.0 liters or > 75% of predicted for height and age.
• Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, or serious cardiac arrhythmias. Patients over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia.
• CNS: No history of brain metastases.
• Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
• Appropriate Contraception in both sexes

EXCLUSION CRITERIA

• Patients may have not have been treated previously with IL-2, IFNα or autologous vaccine.
• Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
• In patients with a prior history of invasive malignancy, less than five years in complete remission
• Positive serology for HIV, hepatitis B or hepatitis C,
• Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen.
• Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 4 weeks must have passed since the last dose).
• History of autoimmune disease.