RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Condition	Treatment or Intervention	Phase
stage IV prostate cancer adenocarcinoma of the prostate recurrent prostate cancer	Drug: APC8015  Drug: prostatic acid phosphatase-sargramostim fusion protein	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4. Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression. Patients are followed monthly for up to 3 years or until disease progression. At the time of disease progression, patients treated on arm II may receive treatment on Protocol D9903.

PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven hormone refractory adenocarcinoma of the prostate that is asymptomatic; Must have soft tissue and/or bony metastases; No visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites)
• At least 25% of tumor cells staining positive for prostatic acid phosphatase by immunohistochemistry
• PSA at least 5 ng/mL
• Tumor progression after hormonal therapy
• No cancer related pain and no regular requirement for analgesics

--Prior/Concurrent Therapy--

• Biologic therapy: No prior biologic therapy
• Chemotherapy: No more than 1 prior chemotherapy regimen
• Endocrine therapy: See Disease Characteristics; More than 1 year since prior corticosteroids except replacement systemic steroids and inhaled, intranasal, or topical corticosteroids; No concurrent antiandrogen therapy; Concurrent LHRH agonists allowed
• Radiotherapy: No prior radiopharmaceutical therapy; At least 4 weeks since other prior radiotherapy and recovered
• Surgery: At least 4 weeks since prior surgery and recovered
• Other: No concurrent herbal therapy; Concurrent bisphosphonates allowed if started at least 30 days before enrollment and continued for duration of study

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0 or 1
• Life expectancy: At least 16 weeks
• Hematopoietic: WBC at least 2,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL
• Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); ALT and AST no greater than 5 times ULN; Hepatitis B surface antigen and hepatitis C antibody negative
• Renal: Creatinine no greater than 2.0 mg/dL
• Other: HIV1, HIV2, and HTLV-1 negative; No active bacterial, viral, or fungal infection; No other malignancy except: Basal cell or squamous cell skin cancer within the past 3 years OR Stage I or II other cancers within the past 5 years; No psychologic, familial, sociologic, geographic, or other medical condition that would preclude study

California
      Cancer and Blood Institute of the Desert, Rancho Mirage,  California,  92270,  United States
      Cancer Center and Beckman Research Institute, City of Hope, Duarte,  California,  91010-3000,  United States
      Eisenhower Medical Center, Rancho Mirage,  California,  92270,  United States
      Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States
      Office of Glenn Tisman, Whittier,  California,  90601,  United States
      Sidney Kimmel Cancer Center, San Diego,  California,  92121,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States
Florida
      Office of Barry S. Berman, Orlando,  Florida,  32806,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
New Jersey
      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States
      Morristown Memorial Hospital, Morristown,  New Jersey,  07962-1956,  United States
      St. Barnabas Medical Center, Livingston,  New Jersey,  07039,  United States
New York
      Albany Regional Cancer Center, Albany,  New York,  12208,  United States
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States
      Center for Medical Oncology, Garden City,  New York,  11530,  United States
      New York Medical College, Valhalla,  New York,  10595,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States
      St. Luke's-Roosevelt Hospital, New York,  New York,  10019,  United States
      St. Vincents Comprehensive Cancer Center, New York,  New York,  10011,  United States
      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States
Ohio
      AKSM Clinical Research Corporation, Columbus,  Ohio,  43214,  United States
Oregon
      Earle A. Chiles Research Institute at Providence Portland Medical Center, Portland,  Oregon,  97213-2967,  United States
Pennsylvania
      Abington Hematology Oncology Associates, Incorporated, Abington,  Pennsylvania,  19001,  United States
      Bryn Mawr Urology, Bryn Mawr,  Pennsylvania,  19010,  United States
      Hematology/Oncology Associates of NE Pennsylvania, P.C., Scranton,  Pennsylvania,  18510,  United States
      North Penn Hospital, Lansdale,  Pennsylvania,  19446-1200,  United States
      Office of Guy Bernstein, M.D., Bryn Mawr,  Pennsylvania,  19010,  United States
      Saint Mary Regional Cancer Center, Langhorne,  Pennsylvania,  19047,  United States
Texas
      American Oncology Resources, Dallas,  Texas,  75246,  United States
Virginia
      Devine Tidewater Urology, Norfolk,  Virginia,  23507,  United States
Washington
      Cancer Care Northwest, Spokane,  Washington,  99202,  United States
      Hematology Oncology Northwest, P.C., Tacoma,  Washington,  98405,  United States
      Seattle Cancer Care Alliance, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

Eric J. Small,  Study Chair,  Dendreon   

Study ID Numbers:  CDR0000067868; DEN-D9901; NCI-G00-1789
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005947
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08