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Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Randomized Study of Vaccine Treatment of Advanced Prostate Cancer


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Howard L. Kaufman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067036

NCT ID:

NCT00003871

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901