This study will evaluate the safety and side effects of two experimental vaccines in patients
with kidney cancer and determine whether the vaccines "turn on" an immune response to the
cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast
growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based
liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune
response to the vaccine.
Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney
or whose primary kidney tumor has been removed within 6 months before entering the study and
are at high risk for disease recurrence may be eligible for this study. Patients must have
tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human
leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test
for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide.
Candidates are screened with a physical examination, blood and urine tests, electrocardiogram
(EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose
tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if
current scans are not available.
Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to
receive the vaccine appropriate for their HLA type. They are then further divided into three
groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with
interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps
fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients
who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has
been surgically removed but who are at risk for recurrence.
Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for
up to a year, or until their tumor grows (or returns in patients in Group 3) or the side
effects are too severe to continue. Tumors are evaluated with a physical examination and
scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2
receive two peptide injections every day for 4 days, along with doses of IL-2 starting the
day after the first peptide injection. The vaccines are given as injections under the skin of
the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses,
depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor
evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment
cycle to receive the IL-2.
All patients undergo leukapheresis, a procedure for collecting large numbers of white blood
cells. Blood is collected through a needle in an arm vein and flows through a cell separator
machine, where the white cells are extracted. The rest of the blood is returned to the
patient through the same needle or a needle in the other arm. The white cells are examined to
evaluate how the vaccines change the action of immune cells. Some patients may undergo an
additional biopsy of normal skin and tumor or lymph node to look at the effects of the
vaccine on the immune cells in the tumor.
Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be
offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the
disease responds to IL-2, the treatment may be repeated after 2 months.