Open Label Study of Sipuleucel-T

Prostate Cancer Clinical Trial

Official title:

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901342
• Other study ID #: P09-1
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2009
• Last updated: October 5, 2015
• Start date: August 2009
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Texas Oncology, PA - Sammons Cancer Center	Dallas	Texas
United States	GU Oncology Research Program	Durham	North Carolina
United States	Hematology Oncology Consultants	Greenbelt	Maryland
United States	Myron I. Murdock MD LLC	Greenbelt	Maryland
United States	Indiana University Department of Urology	Indianapolis	Indiana
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine Department of Urology	New York	New York
United States	NYU Cancer Institute	New York	New York
United States	Urology of Virginia/ Sentara	Norfolk	Virginia
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Maine Center for Cancer Medicine	Scarborough	Maine
United States	Virginia Mason Medical Center Urology and Renal Transplantation	Seattle	Washington
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Aurora Advanced Healthcare, Inc	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore the correlation between immune response and survival.		2010	No
Primary	Evaluate the magnitude of immune responses to treatment with sipuleucel-T		2010	No
Secondary	Obtain additional safety data for sipuleucel-T	Safety will be assessed by summarizing adverse events (AEs), laboratory evaluations, and vital signs	2010	No

External Links

•   Prostate Cancer Research Institute
•   USTOO International