Vaccination of Prostate Cancer Patients With MUC-1-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Examining the Immunogenicity of MUC-1 Glycopeptide Conjugate

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer No radiographic evidence
of metastatic disease Must show signs of disease progression 3 or more rising PSA values
documented, taken at no less than weekly intervals, to greater than 50% above baseline PSA
PSA at least 1.0 ng/mL (post prostatectomy) OR 2.0 ng/mL (post radiation) Evaluable
disease by serial changes in PSA Progression after primary therapy to include surgery or
radiotherapy (with or without neoadjuvant androgen ablation), or intermittent hormonal
therapy with noncastrate levels of testosterone (greater than 50 ng/mL) allowed No soft
tissue and/or bone disease or androgen independent disease with no evidence of
radiographic disease No symptomatic disease or anticipated to be symptomatic within 6
months No active CNS or epidural tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL OR SGOT less than 3 times upper
limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at
least 40 mL/min Cardiovascular: No New York Heart Association class III-IV heart disease
Pulmonary: No severe debilitating pulmonary disease Other: No other malignancy within past
5 years except nonmelanoma skin cancer No concurrent infection requiring antibiotics No
narcotic dependent pain No positive stool guaiac excluding hemorrhoids No history of
documented radiation induced proctitis No allergy to seafood

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No
other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and
recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At
least 2 weeks since prior changes in hormonal therapy including prednisone or
dexamethasone At least 8 weeks since prior suramin OR documented plasma concentration less
than 50 mg/mL (replacement doses of hydrocortisone allowed) Radiotherapy: See Disease
Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent
radiotherapy to only measurable lesion Surgery: See Disease Characteristics No concurrent
surgery Other: No other concurrent anticancer agents