Vaccine Treatment of Kidney Cancer

* INCLUSION CRITERIA

Patients will be screened for inclusion on this study while participating in the Surgery Branch protocol 99-C-0128: Evaluation for the National Cancer Institute (NCI) Surgery Branch Clinical Research Protocols

Patients with clear cell renal carcinoma must fall into one of the two following groups:

For cohort A and B, patients must have measurable metastatic renal cancer and fibroblast growth factor 5 (FGF-5) tumor expression. For cohort C, patients are required to have had a Stage III primary tumor (i.e. T3/T4 or N1/N2) excised within the last 6 months.

Patients must be greater than or equal to 16.

Expected survival must be greater than three months

Patients in cohorts A and B must have tumor sites safely accessible for biopsy or indications for resection of a site of tumor (e.g. an indicated nephrectomy or symptomatic metastasis) and have FGF-5 expression determined by RT-PCR (reverse transcription polymerase chain reaction) and will only be eligible if it is detectable.

Must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) or HLA-A3+.

Serum creatinine of 2.0 mg/dl or less.

Bilirubin 1.6 mg/dl or less, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl.

White blood cell (WBC) 3000/mm or greater.

Platelet count 90,000mm\^3 or greater.

Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less then three times normal.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Patients of both genders must be willing to practice effective birth control during this trial and for three months after active treatment on this trial.

Patients who have received previous low dose interleukin-2 (IL-2) (less than 600,000 IU/kg Food and Drug Administration (FDA) approved dosing regimen) will be eligible.

For cohort A for each human leukocyte antigen (HLA) type, if there are no clinical responses to vaccine alone in the first 12 patients enrolled, subsequent patients must be eligible to receive high-dose IL-2.

Patients must be able to understand and sign the informed consent document.

Eligibility for administration of IL-2.

Patients must meet the following criteria to be eligible to receive IL-2:

Patients may not have active major medical illnesses such as cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.

Patients with recent prolonged history of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test as evidenced by a forced expiratory volume in 1 second (FEV1) greater than 60% predicted.

Patients with electrocardiogram (EKG) abnormalities, symptoms of cardiac ischemia or arrhythmias or age greater than 50 years will have a normal stress cardiac test (stress thallium, stress multi-gated acquisition scan (MUGA), dobutamine echocardiogram or other stress test).

Patients must be willing to sign a durable power of attorney (DPA).

Serum creatinine of 2.0 mg/dl or less.

Total bilirubin 2.0 mg/dl or less, except in patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl.

White blood cell (WBC) 3000/mm\^3 or greater.

Platelet count 90,000 mm\^3 or greater.

EXCLUSION CRITERIA:

Patients will be excluded:

Who are not willing or able to be biopsied.

Who are undergoing or have undergone in the past 3 weeks any other form of therapy for their cancer, or have undergone nitrosurea therapy within the past 6 weeks. All patients toxicities must have recovered to a grade 1 or less. Patients may have undergone minor surgical procedures or local radiotherapy within the past 3 weeks as long as all toxicities have recovered to a grade 1 or less.

Have active systemic infections, coagulation disorder, or other major medical illnesses of the cardiovascular or respiratory symptoms or any known immunodeficiency disease (Immune competence will be defined as lymphocyte count greater than 500 (grade 3 toxicity in Common Toxicity Criteria (CTC) 3); white blood cell (WBC) 1000; and absence of opportunistic infections).

Who require systemic steroid therapy.

Who are pregnant (because of possible side effects on the fetus) or who are breastfeeding, or who are unwilling/unable to practice effective birth control.

Who are known to be positive for hepatitis BsAG, or human immunodeficiency virus (HIV) antibody, or hepatitis C antibody (unless antigen negative), (because of possible immune effects of these conditions).

Who have had a known allergic reaction to Incomplete Freund's Adjuvant (MONTANIDE ISA-51) or hypersensitivity to any agent used on this protocol.

Who have a fresh tumor specimen with no evidence of FGF-5 expression on a technically adequate RT-PCR assessment.