Trial record 1 of 3 for:
p10-1
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 February 2013 by Dendreon
Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01338012
First received: March 2, 2011
Last updated: February 21, 2013
Last verified: February 2013
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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, 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: | February 21, 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 May 21, 2013