RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of PSA vaccines in treating patients who have advanced prostate cancer.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer recurrent prostate cancer	Drug: fowlpox virus vaccine  Drug: vaccinia-prostate-specific antigen vaccine	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the effect of prime and boost strategies using recombinant fowlpox prostate specific antigen (PSA) vaccine and recombinant vaccinia PSA vaccine on biochemical PSA progression in patients with stage D0 prostate cancer who have completed local treatment.

II. Assess the tolerability and toxicity of these prime and boost treatment regimens in these patients.

III. Evaluate the effects of these prime and boost treatment regimens on cellular immunity in these patients.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to HLA-2 typing (positive vs negative vs unknown). Patients are randomized to one of three treatment arms.

Arm I: Patients receive intramuscular fowlpox prostate specific antigen (PSA) vaccine at weeks 0, 6, 12, and 18.

Arm II: Patients receive intramuscular fowlpox PSA vaccine at weeks 0, 6, and 12 and intradermal vaccinia PSA vaccine at week 18.

Arm III: Patients receive intradermal vaccinia PSA vaccine at week 0 and intramuscular fowlpox PSA vaccine at weeks 6, 12, and 18.

Patients are followed at week 24, then every 3 months until year 2, every 6 months until year 5, and annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven prostate cancer limited to the prostate (including seminal vesicle and/or local lymph node involvement) with elevated PSA (greater than 2 ng/ml) following surgery or rising PSA following radiotherapy
• Negative bone scan and CT scan of abdomen and pelvis
• No PSA progression during chemotherapy, hormonal therapy (including steroids), or neoadjuvant or adjuvant androgen ablation therapy

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; At least 6 months since prior chemotherapy and recovered
• Endocrine therapy: See Disease Characteristics; At least 6 months since prior hormonal therapy (including steroids) and recovered
• Radiotherapy: See Disease Characteristics; At least 3 months since prior radiotherapy of prostate and recovered
• Surgery: See Disease Characteristics; At least 3 months since prior prostate surgery and recovered
• Other: Prior vaccinia immunization required OR Patient recollection of immunization and appropriate vaccination site scar

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: At least 6 months
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal; Bilirubin no greater than 1.5 mg/dL
• Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min
• Cardiovascular: Not specified
• Pulmonary: Not specified
• Other: No active untreated infection; No known infection with HIV; No concurrent medical conditions that would prevent compliance; No history or evidence of active eczema or psoriasis or other contraindications to vaccinia virus administration (i.e., allergy); No significant allergy or hypersensitivity to eggs; No evidence of immunosuppression; Must be able to avoid contact with high risk individuals (immunosuppressed patients, children under 3, pregnant women, or patients with a history of or active eczema or other exfoliative diseases) for 7-10 days after immunization (household contacts must not be high risk); Fertile patients must use effective contraception

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States
New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States

Study chairs or principal investigators

Howard L. Kaufman,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000067036; E-7897
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003871
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08