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

April 21, 2017 updated by: Dendreon

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093-0820
        • UCSD Moores Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente
      • Portland, Oregon, United States, 97213
        • Providence Medical Center
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists
    • Virginia
      • Norfolk, Virginia, United States, 23503
        • Urology of Virginia, Sentara Medical Group
    • Washington
      • Seattle, Washington, United States, 98102
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center Urology and Renal Transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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)
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.
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)
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Months 2, 4 and 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 11, 2008

First Submitted That Met QC Criteria

July 14, 2008

First Posted (Estimate)

July 15, 2008

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P07-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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