PSA Vaccine Therapy in Treating Patients With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003871
Recruitment Status : Completed
First Posted : June 16, 2004
Last Update Posted : January 27, 2010
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Biological: fowlpox virus vaccine vector Biological: recombinant vaccinia prostate-specific antigen vaccine Phase 2

Detailed Description:

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.

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer
Study Start Date : August 1999
Actual Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003871

United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Wisconsin
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Howard L. Kaufman, MD Albert Einstein College of Medicine, Inc.

Publications of Results:
Kaufman HL, Wang W, Manola J, et al.: Phase II prime/boost vaccination using poxviruses expressing PSA in hormone dependent prostate cancer: follow-up clinical results from ECOG 7897. [Abstract] J Clin Oncol 23 (Suppl 16): A-4501, 378s, 2005.
Kaufman HL, Wang W, Manola J, et al.: Prime/boost vaccination using poxviruses expressing PSA in D0 prostate cancer: preliminary results of ECOG 7897, a randomized phase II clinical trial. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-12, 2002.

Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00003871     History of Changes
Other Study ID Numbers: CDR0000067036
First Posted: June 16, 2004    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010

Keywords provided by Eastern Cooperative Oncology Group:
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunologic Factors
Physiological Effects of Drugs