Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Experimental
Arm I
atients in cohorts of 3-6 receive 3 vaccinations with rV-PSA at 4-week intervals (days 1, 29, 57, and 85) in the absence of disease progression or unacceptable toxicity. Response assessment is performed at eight weeks. Patients who discontinue therapy prior to eight weeks are considered unevaluable for response. If dose limiting toxicity is observed in 2 of 6 patients entered at a dose level, no further patients are entered at that level and the MTD is defined as the preceding dose level. Ten additional patients are treated at the MTD and receive granulocyte-macrophage colony-stimulating factor (GM-CSF) administered subcutaneously on day -1 through day 2 of each cycle. Patients who are HLA-A2 positive, have received all 3 rV-PSA vaccinations without unacceptable toxicity, and have been off study for at least 30 days due to disease progression may continue treatment with rV-PSA at the highest dose level and the addition of GM-CSF.