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 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN, serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome)
Renal: serum creatinine < 2.0 x ULN.
Pulmonary: FEV1 > 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.