To Evaluate Sipuleucel-T Manufactured With Different Concentrations of Prostate Adenocarcinoma (PA2024) Antigen (ProACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00715078
First received: July 11, 2008
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen


Condition Intervention Phase
Prostate Cancer
Biological: Sipuleucel-T
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Compare the Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [ Time Frame: Baseline and up to week 36 ] [ Designated as safety issue: No ]
    An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.


Secondary Outcome Measures:
  • Evaluate the Magnitude of the Immune Response in Each of the Cohorts. [ Time Frame: Overall survival will be evaluated after the last living subject has completed the Month 36 visit. ] [ Designated as safety issue: Yes ]
  • Evaluate the Overall Survival in Each of the Cohorts. [ Time Frame: Overall survival will be evaluated after the last living subject has completed the Month 36 visit. ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: August 2008
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort A
Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 107 peripheral blood mononuclear cells (PBMCs) per mL
Biological: Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with prostate antigen PA2024.
Active Comparator: Cohort B
Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
Biological: Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with prostate antigen PA2024.
Active Comparator: Cohort C
Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 107 PBMCs per mL
Biological: Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with prostate antigen PA2024.

Detailed Description:

This is a multicenter, single blind, Phase 2 study. Subjects will receive the investigational product, sipuleucel-T, manufactured with 1 of 3 different concentrations of PA2024 antigen. The purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects. The study will also evaluate the levels of immune response, the length of survival, the role of circulating tumor cell levels in the blood, and changes in quality of life in each of the 3 groups of subjects. All subjects will be blinded to their cohort assignment to ensure unbiased completion of the quality of life (QOL) questionnaires. All subjects will be followed for this study for the remainder of their lives.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

  • Histologically documented adenocarcinoma of the prostate.
  • Metastatic disease.
  • Progressive androgen independent prostate cancer.
  • Serum PSA >= 5.0 ng/mL.
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
  • Men >= 18 years of age.
  • Adequate hematologic, renal and liver function.
  • In order to ensure the integrity of the study data is maintained, study participants must be able to complete all study visits. For this reason, study participation is limited to those who live in a permanent residence within a comfortable driving distance (roundtrip within one day) to the clinical research site.

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

  • The presence of known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
  • A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
  • Moderate to severe disease related pain.
  • Eastern Cooperative Oncology Group (ECOG) performance status >= 2 .
  • Use of non-steroidal antiandrogens within 6 weeks of registration.
  • Anti-androgen withdrawal response.
  • Treatment with chemotherapy within 3 months of registration.
  • More than 2 chemotherapy regimens prior to registration.
  • Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
  • Treatment with any of the following medications or interventions within 28 days of registration:

    • Systemic corticosteroids,
    • External beam radiation therapy or surgery,
    • Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., PC-SPES or PC-SPEC) and saw palmetto,
    • Megestrol acetate (Megace(R)), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
    • 5-alpha-reductase inhibitors,
    • High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mg/day).
  • Any other systemic therapy for prostate cancer (except for medical castration).
  • Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
  • Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
  • Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
  • A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for >= 3 years at the time of registration.
  • A requirement for systemic immunosuppressive therapy for any reason.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor (GM-CSF).
  • Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
  • Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715078

Locations
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0820
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Providence Medical Center
Portland, Oregon, United States, 97213
Kaiser Permanente
Portland, Oregon, United States, 97227
Northwest Cancer Specialists
Portland, Oregon, United States, 97227
United States, Virginia
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, United States, 23503
United States, Washington
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Dendreon
Investigators
Principal Investigator: Candice McCoy, MD Dendreon
  More Information

Additional Information:
No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00715078     History of Changes
Other Study ID Numbers: P07-2
Study First Received: July 11, 2008
Results First Received: February 19, 2014
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
prostate specific antigen (PSA)
prostatic adenocarcinoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014