A PHASE I TRIAL OF RECOMBINANT VACCINIA VIRUS THAT EXPRESSES PSA IN PATIENTS WITH ADENOCARCINOMA OF THE PROSTATE

Date de début de l'étude : 1 décembre 1996

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease based on any of the following: Lymph node positive and PSA at least 10 ng/mL Bone scan positive and PSA at least 10 ng/mL PSA at least 2 ng/mL and rising following radical prostatectomy PSA at least 10 ng/mL following radiotherapy No symptomatic metastatic disease (bony pain) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 WBC greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Bilirubin less than 2.0 mg/dL AST less than 4 times normal Creatinine less than 2.0 mg/dL Must be type HLA-A2 Prior vaccinia (smallpox) exposure required At least normal delayed type hypersensitivity to mumps and Candida At least normal CD4:CD8 ratio (greater than 1) At least normal lymphocyte proliferation testing (to Con A) At least normal immunoglobulin levels No evidence of altered immune responsiveness or autoimmune syndromes (e.g., scleroderma, systemic lupus erythematosus) No HIV antibody No prior splenectomy No known allergy to eggs No active extensive skin disorders (e.g, psoriasis, burns, impetigo, disseminated zoster) No other serious intercurrent illness No active infections unless cleared and at least 3 days since antibiotic therapy No close contact for 2 weeks after each vaccination with the following people: Children less than 3 years old Pregnant women Individuals with eczema or skin conditions listed above Immunosuppressed individuals PRIOR CONCURRENT THERAPY: No concurrent biologic therapy No prior chemotherapy for metastatic disease No prior hormone therapy for metastatic disease Neoadjuvant hormone therapy prior to prostatectomy or radiotherapy allowed No concurrent steroids or hormonal medications Prior radiotherapy allowed Prior surgery allowed