Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402)
Information source: Dendreon
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: sipuleucel-T (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Dendreon Official(s) and/or principal investigator(s):
Robert Sims, MD, Study Director, Affiliation: Dendreon
Summary
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.
Clinical Details
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)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the immune response generated by sipuleucel-T
Secondary outcome: To evaluate the safety of sipuleucel-TTo explore the correlation between sipuleucel-T immune response and overall survival.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
South Orange County Medical Research Center, Laguna Hills, California 92653, United States; Recruiting
Erika Pirtle, CCRC, Phone: 949-215-9515, Ext: 1, Email: epirtle@urologymedical.com
Richard H Greengold, MD, Principal Investigator
University of Colorado Cancer Center, Aurora, Colorado 80045, United States; Recruiting
Nikki Chronister, BSN, CCRP, Phone: 720-848-0602, Email: nicole.chronister@ucdenver.edu
Michael Glode, MD, Principal Investigator
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Seonaid Squires, Phone: 503-418-9104, Email: squiress@ohsu.edu
Tomasz Beer, MD, Principal Investigator
Urology of Virginia, Virginia Beach, Virginia 23462, United States; Recruiting
Jennifer Kucenski, Phone: 757-452-3462, Email: jkucenski@urologyofva.net
Robert Given, MD, Principal Investigator
Virginia Mason Medical Center, Seattle, Washington 98101, United States; Recruiting
Kathryn Dahl, RN, Phone: 206-341-0578, Email: kathryn.dahl@vmmc.org
John M Corman, MD, Principal Investigator
Virginia Mason Hospital, Seattle, Washington 98101, United States; Recruiting
Kathryn Dahl, RN, Phone: 206-341-0578, Email: kathryn.dahl@vmmc.org
John M Corman, MD, Principal Investigator
Additional Information
Starting date: November 2011
Last updated: November 1, 2012
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