Trial record 2 of 18 for:
"Dendreon" [Exact]
Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer (NeoACT)
This study is ongoing, but not recruiting participants.
Sponsor:
Dendreon
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00715104
First received: July 11, 2008
Last updated: April 19, 2013
Last verified: April 2013
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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 2 |
| 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:
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 Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: 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.
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:
No publications provided
| Responsible Party: | Dendreon |
| ClinicalTrials.gov Identifier: | NCT00715104 History of Changes |
| Other Study ID Numbers: | P07-1 |
| Study First Received: | July 11, 2008 |
| Last Updated: | April 19, 2013 |
| 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 May 23, 2013