Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402)

This study is currently recruiting participants.
Verified October 2013 by Dendreon
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01338012
First received: March 2, 2011
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

This study is being conducted to examine the immune response generated by sipuleucel-T in subjects previously treated with sipuleucel-T in the androgen dependent setting. The study will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial sites. The anticipated duration of the study is approximately 6 years.


Condition Intervention Phase
Prostate Cancer
Drug: sipuleucel-T
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • To evaluate the immune response generated by sipuleucel-T [ Time Frame: Change in immune response from Baseline through Month 12 ] [ Designated as safety issue: No ]
    Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)


Secondary Outcome Measures:
  • To evaluate the safety of sipuleucel-T [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
    Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, and physical examination findings.

  • To explore the correlation between sipuleucel-T immune response and overall survival. [ Time Frame: Baseline to study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Drug: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Name: PROVENGE, APC8015

  Eligibility

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

Inclusion Criteria:

  • Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
  • Radiologic evidence of metastasis
  • Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
  • Adequate hematologic function

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Treatment with chemotherapy within 3 months prior to registration
  • Treatment with systemic corticosteroids, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
  • Current or imminent pathologic long-bone fracture
  • Known malignancies other than prostate cancer that are likely to require treatment within 6 months following 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 GM-CSF
  • Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
  • Any surgery requiring general anesthetic within 28 days prior to registration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338012

Locations
United States, California
South Orange County Medical Research Center Recruiting
Laguna Hills, California, United States, 92653
Contact: Erika Pirtle, CCRC    949-215-9515 ext 1    epirtle@urologymedical.com   
Principal Investigator: Richard H Greengold, MD         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Nikki Chronister, BSN, CCRP    720-848-0602    nicole.chronister@ucdenver.edu   
Principal Investigator: Michael Glode, MD         
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Cynthia Knauer    212-241-8121    Cynthia.Knauer@mountsinai.org   
Principal Investigator: Simon Hall, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Seonaid Squires    503-418-9104    squiress@ohsu.edu   
Principal Investigator: Tomasz Beer, MD         
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
Contact: Jennifer Kucenski    757-452-3462    jkucenski@urologyofva.net   
Principal Investigator: Robert Given, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kathryn Dahl, RN    206-341-0578    kathryn.dahl@vmmc.org   
Principal Investigator: John M Corman, MD         
Virginia Mason Hospital Recruiting
Seattle, Washington, United States, 98101
Contact: Kathryn Dahl, RN    206-341-0578    kathryn.dahl@vmmc.org   
Principal Investigator: John M Corman, MD         
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Sims, MD Dendreon
  More Information

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01338012     History of Changes
Other Study ID Numbers: P10-1
Study First Received: March 2, 2011
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
metastatic castrate resistant prostate cancer
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
PSA
prostatic adenocarcinoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014