Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21

Exclusion Criteria

• •Hormonal status will be recorded on the basis of serum testosterone levels.
• •Patients should have no change in their hormone therapies (with the exception of therapies needed to maintain castrate levels of testosterone), including prednisone or dexamethasone within two weeks prior to entry into study.
• •Patients must have evaluable disease (by serial changes in PSA).
• •Karnofsky performance status \>60%.
• •Patients must have adequate organ function as defined by:
• •WBC \> or = to 3500/mm3 platelet count \> or = to 100,000 mm3.
• •Bilirubin \< or = 2.0 rag/100 ml or SGOT \<3.0 X's the upper limit of normal.
• •Creatinine \< or = 2.0 mg/100 ml or creatinine clearance \> or = 40 cc/min.
• •Patients must have recovered from the toxicity of any prior therapy, and not received chemotherapy or radiation therapy for at least 4 weeks prior to entry into the trial.
• •No history of an active secondary malignancy within the prior five years except for nonmelanoma skin cancer.
• •Patients must be at least 18 years of age.
• •Patients who have previously received suramin, may be treated if they have been off this drug for at least 8 weeks and/or ha ve a documented plasma concentration below 50 mg/ml. For these patients, replacement doses of hydrocortisone are permitted.
• •Patients must sign informed consent.
• •Registration to IRB Protocol 90-40 (Correlative studies in human prostate cancer).
• •Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• •Active CNS or epidural tumor.
• •An infection requiring antibiotic treatment.
• •Narcotic dependent pain.
• •Anticipated survival of less than 6 months.
• •Positive stool guaiac excluding hemorrhoids or history of documented radiation induced proctitis.
• •Allergy to seafood.
• •Patients with radiographic evidence of metastatic disease.