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: October 25, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 7, 2009
Last Updated Date	October 25, 2012
Start Date ^ICMJE	August 2009
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 11, 2009)	Evaluate the magnitude of immune responses to treatment with sipuleucel-T [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00901342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 8, 2010)	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
Original Secondary Outcome Measures ^ICMJE (submitted: May 11, 2009)	Obtain additional safety data for sipuleucel-T [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE (submitted: October 25, 2012)	To explore the correlation between immune response and survival. [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open Label Study of Sipuleucel-T
Official Title ^ICMJE	An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Brief Summary	This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	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.
Study Arm (s)	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. Intervention: Drug: Sipuleucel-T
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00901342
Other Study ID Numbers ^ICMJE	P09-1
Has Data Monitoring Committee	No
Responsible Party	Dendreon
Study Sponsor ^ICMJE	Dendreon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dendreon
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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