Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

April 21, 2017 updated by: Dendreon

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Study Type

Interventional

Enrollment (Actual)

104

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
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Department of Urology
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Hematology Oncology Consultants
      • Greenbelt, Maryland, United States, 20770
        • Myron I. Murdock MD LLC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • NYU Cancer Institute
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine Department of Urology
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GU Oncology Research Program
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care, Inc.
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology, PA - Sammons Cancer Center
    • Virginia
      • Virginia Beach, Virginia, United States, 23642
        • Urology of Virginia, PLLC
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center Urology and Renal Transplantation
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Advanced Healthcare, Inc

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:

  • Histologically documented adenocarcinoma of the prostate
  • Metastatic disease
  • Castrate resistant prostate cancer
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
  • Life expectancy of ≥ 3 months
  • Men ≥ 18 years of age
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Presence of known lung, liver, or brain metastases
  • Evidence of neuroendocrine or small cell features
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
  • Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
  • Known malignancies other than prostate cancer that are likely to require treatment within six months 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 > 100.5F or > 38.1C) 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

Treatment with any of the following medications or interventions within 28 days of registration:

  • Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
  • Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
  • External beam radiation therapy or major surgery requiring general anesthetic
  • Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
  • Chemotherapy
  • Treatment with any other investigational product

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sipuleucel-T
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)
Other Names:
  • • Provenge® • APC8015

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
Time Frame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Day 0 (first infusion) and up to 3 infusions at 2-week intervals

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, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 7, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 13, 2009

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

  • P09-1

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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