• Clinical response (cohorts A and B) [ Designated as safety issue: No ]
• Immunological response (cohort C) [ Designated as safety issue: No ]

• Clinical response (cohorts A and B)
• Immunological response (cohort C)

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV kidney cancer.

OBJECTIVES:

Primary

• Determine the overall response rates in patients with stage IV clear cell renal cell carcinoma treated with vaccine comprising HLA-A2- and HLA-A3-binding peptides from fibroblast growth factor-5 emulsified in Montanide ISA-51. (Cohorts A and B)
• Determine the effect of this vaccine on the response rate to high-dose interleukin-2 in these patients. (Cohorts A and B)
• Determine the immunologic response in patients with stage III clear cell renal cell carcinoma at high risk for relapse treated with this vaccine.

(Cohort C)

• Determine the toxicity of this vaccine in these patients.

Secondary

• Determine the immunologic response in patients with stage IV disease treated with this vaccine. (Cohorts A and B)

OUTLINE: Patients are stratified according to class I haplotype (HLA-A2 vs HLA-A3). Patients are assigned to 1 of 3 cohorts.

• Cohort A (no requirement for immediate interleukin-2 [IL-2] therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from fibroblast growth factor-5 (FGF-5) emulsified in Montanide ISA-51 subcutaneously (SC) once daily on days 1-4. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients eligible for IL-2 who have not yet received it have high-dose IL-2 added to their regimen. Patients continue to receive peptide vaccination on days 1-4 and receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year of total treatment.
• Cohort B (requirement for immediate IL-2 therapy): Patients receive vaccination comprising the HLA-appropriate binding peptide from FGF-5 emulsified in Montanide ISA-51 SC once daily on days 1-4. Patients also receive high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (12 doses). Treatment repeats every 15-19 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
• Cohort C: Patients receive peptide vaccination as in cohort A. At the time of relapse, patients have high-dose IL-2 added to their regimen as in cohort A. Treatment repeats every 15-19 days for up to 6 months of total treatment.

Patients are followed every 3-6 months (cohorts A and B) OR every 3 months for 1 year and then every 6-12 months thereafter (cohort C).

PROJECTED ACCRUAL: A total of 36-210 patients (12-80 in cohort A, 12-66 in cohort B, and 12-64 in cohort C) will be accrued for this study within 5 years.

• Biological: HLA-A2, A3-restricted FGF-5 peptides/Montanide ISA-51 vaccine
• Biological: aldesleukin
• Procedure: adjuvant therapy

DISEASE CHARACTERISTICS:

• Histologically confirmed clear cell renal cell carcinoma meeting one of the following criteria:

  • Measurable metastatic disease (cohorts A and B)

    • Tumor site must be safely accessible for biopsy OR have indications for resection of a tumor site (e.g., indicated nephrectomy or symptomatic metastasis)
  • Stage III primary tumor (i.e., T3 or T4 OR N1 or N2) removed within the past 6 months AND at high-risk for recurrence (cohort C)
• Detectable fibroblast growth factor-5 tumor expression by reverse transcription polymerase chain reaction
• Patients must be HLA-A2- or HLA-A3-positive

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 90,000/mm^3
• No coagulation disorders

Hepatic

• AST and ALT < 3 times normal
• Bilirubin ≤ 1.6 mg/dL (< 3.0 mg/dL for patients with Gilbert's disease)
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative (unless antigen negative)

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• Cardiac stress test normal in patients with EKG abnormalities, symptoms of cardiac ischemia, arrhythmias, or > 50 years old*
• No cardiac ischemia*
• No myocardial infarction*
• No cardiac arrhythmias*
• No other major medical illness of the cardiovascular system NOTE: *Eligibility for IL-2 administration

Pulmonary

• FEV_1 > 60% of predicted for patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction*
• No obstructive or restrictive pulmonary disease*
• No other major medical illness of the respiratory system NOTE: *Eligibility for IL-2 administration

Immunologic

• HIV negative
• No active systemic infections

• No known immunodeficiency disease

  • Immune competence is defined as lymphocyte count > 500/mm^3, WBC ≥ 1,000/mm^3, and no opportunistic infections
• No known allergic reaction to Montanide ISA-51
• No hypersensitivity to any agent used in this study

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study participation
• Willing or able to undergo biopsy
• No other active major medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior low-dose interleukin-2 (IL-2) (less than 600,000 IU/kg) allowed

Chemotherapy

• More than 6 weeks since prior nitrosoureas

Endocrine therapy

• No concurrent systemic steroid therapy

Radiotherapy

• Local radiotherapy within the past 3 weeks allowed

Surgery

• See Disease Characteristics
• Minor surgical procedures within the past 3 weeks allowed

Other

• Recovered from all prior therapy
• More than 3 weeks since any other prior therapy for the malignancy
• No other concurrent therapy for the malignancy