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

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ClinicalTrials.gov Identifier: NCT00715078
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Dendreon

Tracking Information
First Submitted Date  ICMJE July 11, 2008
First Posted Date  ICMJE July 15, 2008
Results First Submitted Date  ICMJE February 19, 2014
Results First Posted Date  ICMJE May 12, 2014
Last Update Posted Date May 23, 2017
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [ Time Frame: Baseline, Months 2, 4 and 6. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
Compare the cumulative CD54 upregulation ratio between each of the cohorts. [ Time Frame: 2010 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
  • 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. ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
Official Title  ICMJE 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
Brief Summary 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
Detailed Description 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 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
Study Arms  ICMJE
  • Active Comparator: Cohort A
    Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
    Intervention: Biological: sipuleucel-T
  • Active Comparator: Cohort B
    Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
    Intervention: Biological: sipuleucel-T
  • Active Comparator: Cohort C
    Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
    Intervention: Biological: sipuleucel-T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2013)
122
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2008)
120
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 castrate resistant prostate cancer.
  • Serum PSA ≥ 5.0 ng/mL.
  • Life expectancy of ≥ 6 months.
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
  • Men ≥ 18 years of age.
  • Adequate hematologic, renal and liver function.

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., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
    • Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
    • 5-alpha-reductase inhibitors,
    • High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00715078
Other Study ID Numbers  ICMJE P07-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dendreon
Study Sponsor  ICMJE Dendreon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
PRS Account Dendreon
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP