Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Open Label Study of Sipuleucel-T

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00901342
First received: May 7, 2009
Last updated: August 7, 2014
Last verified: October 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Evaluate the magnitude of immune responses to treatment with sipuleucel-T [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obtain additional safety data for sipuleucel-T [ Time Frame: 2010 ] [ Designated as safety issue: No ]
    Safety will be assessed by summarizing adverse events (AEs), laboratory evaluations, and vital signs


Other Outcome Measures:
  • To explore the correlation between immune response and survival. [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
Drug: Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Detailed Description:

Subjects will receive the investigational product, sipuleucel-T, at approximately 2-week intervals, for a total of 3 infusions. The study will evaluate the safety of and magnitude of the immune responses to treatment with sipuleucel-T. All subjects will be followed for 30 days following the last infusion of sipuleucel-T. The study is also available to placebo subjects who participated in the D9902B study.

  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.
  • Castrate resistant prostate cancer.
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
  • Life expectancy of at least 3 months.
  • 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.
  • 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 GM-CSF.
  • 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.
  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: NCT00901342

Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana University Department of Urology
Indianapolis, Indiana, United States, 46202
United States, Maine
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Maryland
Hematology Oncology Consultants
Greenbelt, Maryland, United States, 20770
Myron I. Murdock MD LLC
Greenbelt, Maryland, United States, 20770
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai School of Medicine Department of Urology
New York, New York, United States, 10029
NYU Cancer Institute
New York, New York, United States, 10016
United States, North Carolina
GU Oncology Research Program
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, PA - Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Virginia
Urology of Virginia/ Sentara
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, United States, 98101
United States, Wisconsin
Aurora Advanced Healthcare, Inc
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Candice McCoy, MD Dendreon
  More Information

Additional Information:
No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00901342     History of Changes
Other Study ID Numbers: P09-1
Study First Received: May 7, 2009
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
AIPC
CRPC
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 24, 2014