A Phase II Randomized Trial of Recombinant Fowlpox and Recombinant Vaccinia Virus Expressing PSA in Patients With Adenocarcinoma of the Prostate

Study start date: January 1, 2000

Inclusion Criteria: Histologically proven adenocarcinoma of the prostate with evidence of metastatic disease including any of the following: Lymph node positive and prostate-specific antigen (PSA) at least 10 ng/mL Bone scan positive and PSA at least 10 ng/mL Prior radical prostatectomy with rising PSA and PSA at least 2 ng/mL Prior radiotherapy and PSA at least 10 ng/mL Prior cryosurgery and PSA at least 10 ng/mL PSA criteria does not apply to patients who are assigned to group B of this study and were previously treated on vaccine trial DFCI-96079 No symptomatic metastatic disease (no bony pain) Complete HLA typing required Performance status - ECOG 0 or 1 WBC greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin less than 2.0 mg/dL SGPT less than 4 times upper limit of normal Creatinine less than 4.0 mg/dL No altered immune function such as eczema No autoimmune diseases such as the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma Myasthenia gravis Goodpasture's syndrome Addison's disease, Hashimoto's thyroiditis, or active Graves' disease HIV negative No allergy or untoward reaction to prior vaccinia (smallpox) vaccination No hypersensitivity to eggs No prior or concurrent extensive eczema or skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster) No other concurrent serious illness No active infection requiring antibiotics until infection has cleared and antibiotics have been stopped for at least 3 days Fertile patients must use effective contraception No close contact or household contact with the following high-risk individuals for at least 2 weeks after each vaccination: Children under age 5 Pregnant or nursing women Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) Immunodeficient or immunosuppressed individuals (by disease or therapy) such as those with HIV infection See Disease Characteristics See Endocrine therapy Prior vaccinia (smallpox) immunization required No other concurrent biologic therapy (e.g., interferon or interleukin) for cancer No prior chemotherapy for metastatic disease No concurrent anticancer chemotherapy No prior hormonal therapy for metastatic disease Prior neoadjuvant hormonal therapy followed by prostatectomy or radiotherapy allowed Patients previously treated with recombinant vaccinia-PSA vaccine may have hormonal therapy since discontinuing that treatment (Group B) No concurrent hormonal therapy or steroids See Disease Characteristics See Endocrine therapy No concurrent radiotherapy See Disease Characteristics See Endocrine therapy No prior splenectomy At least 3 days since prior antibiotics No concurrent immunosuppressive treatment (e.g., after organ transplantation)