OBJECTIVES:

• Determine the safety and tolerability of NY-ESO-1 peptide vaccine, BCG, and sargramostim (GM-CSF) in post-cystectomy patients with transitional cell carcinoma of the bladder expressing NY-ESO-1 or LAGE-1 antigen.
• Determine the immunological profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.

OUTLINE: This is an open-label, pilot study.

Patients receive NY-ESO-1 peptide vaccine mixed with BCG intradermally (ID) once weekly on weeks 1 and 2. Patients then receive NY-ESO-1 peptide mixed with sargramostim (GM-CSF) ID once weekly on day 2 of weeks 3-6. Patients also receive GM-CSF subcutaneously alone on days 1, 3, 4, and 5 of weeks 3-6. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 and 6 weeks.

PROJECTED ACCRUAL: A total of 24-28 patients (8 HLA-A2 positive with prior intravesical BCG, 8 HLA-A2 positive without prior intravesical BCG, 4-6 HLA-A2 negative with prior intravesical BCG, and 4-6 HLA-A2 negative without prior intravesical BCG) will be accrued for this study within 15 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed transitional cell carcinoma of the bladder
• Tumor expression of NY-ESO-1 by reverse transcription-polymerase chain reaction (RT-PCR) or immunohistochemistry OR LAGE-1 by RT-PCR
• Prior cystectomy within the past 4-16 weeks
• No evidence of disease by radiological imaging within the past month

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Neutrophil count at least 1,500/mm^3
• Lymphocyte count at least 500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10.0 g/dL
• No bleeding disorders

Hepatic

• Bilirubin no greater than 2 mg/dL
• AST and ALT less than 2.5 times upper limit of normal

Renal

• Creatinine no greater than 1.8 mg/dL

Cardiovascular

• No New York Heart Association class III or IV heart disease

Immunologic

• No history of immunodeficiency disease
• No history of autoimmune disease

Other

• HIV negative
• No prior severe reaction to PPD (at least 15 mm induration)
• No other malignancy within the past 5 years that has been treated with extensive chemotherapy/radiotherapy, has the potential for immune dysfunction, or has evidence of metastasis at the time of study entry
• No other serious illness
• No serious infection requiring antibiotics
• No mental disorder that would preclude the ability to give informed consent or comply with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy
• No prior bone marrow or peripheral blood stem cell transplantation

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• No concurrent chemotherapy

Endocrine therapy

• More than 30 days since prior corticosteroids
• No concurrent systemic corticosteroids
• Concurrent topical or inhalational steroids allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 5 days since prior antibiotics
• More than 4 weeks since prior participation in another clinical study
• No concurrent antihistaminic drugs
• No concurrent nonsteroidal anti-inflammatory drugs except low doses for prevention of an acute cardiovascular event or pain control
• No concurrent immunosuppressive agents