Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer - Full Text View

Sponsor:	Dendreon
Collaborator:	University of California, San Francisco
Information provided by:	Dendreon
ClinicalTrials.gov Identifier:	NCT00715104

Purpose

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Biological: Sipuleucel-T	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Provenge Sipuleucel-T

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:

To assess the immune response within prostate tissue following neoadjuvant treatment with sipuleucel-T. [ Time Frame: baseline and at prostatectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other immunological or immunohistochemical tests will be evaluated [ Time Frame: estimated ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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:

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Eligibility

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

Criteria

Inclusion Criteria

Eligible subjects must meet all of the following criteria.

Adenocarcinoma of the prostate.
Subject is scheduled for RP as the initial therapy for localized prostate cancer.
Subject is ≥ 18 years of age.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Subject has adequate hematologic, renal, and liver function.

Exclusion Criteria

A subject is not eligible for study participation if any of the following criteria apply.

Subject has any evidence of metastasis.
Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
Subject has received prior radiation therapy or chemotherapy for prostate cancer.
Subject has received systemic steroid therapy within 14 days.
Subject has a history of stage III or greater cancer, excluding prostate cancer. Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715104

Locations

United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Kaiser Permanente Portland
Portland, Oregon, United States, 97227
United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98102

Sponsors and Collaborators

Dendreon

University of California, San Francisco

Investigators

Study Director:

Robert Sims, MD

Dendreon

More Information

Additional Information:

Prostate Cancer Research Institute This link exits the ClinicalTrials.gov site

USTOO International This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Elizabeth Smith, Dendreon Corporation
ClinicalTrials.gov Identifier:	NCT00715104 History of Changes
Other Study ID Numbers:	P07-1
Study First Received:	July 11, 2008
Last Updated:	July 1, 2011
Health Authority:	United States: Food and Drug Administration

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 February 13, 2012