Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT00901342

Run by

Dendreon

People needed

104

Starts

2009-10-01

Expected to finish

2015-06-01

Last updated by the study team

2017-05-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 3 months
• Men ≥ 18 years of age
• Adequate hematologic, renal and liver function

You may not qualify if…

• 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 granulocyte-macrophage colony-stimulating factor
• 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

Where it is running

• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Indiana University Department of Urology — Indianapolis, Indiana, United States
• Maine Center for Cancer Medicine — Scarborough, Maine, United States
• Hematology Oncology Consultants — Greenbelt, Maryland, United States
• Myron I. Murdock MD LLC — Greenbelt, Maryland, United States
• John Theurer Cancer Center at Hackensack — Hackensack, New Jersey, United States
• NYU Cancer Institute — New York, New York, United States
• Mount Sinai School of Medicine Department of Urology — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• GU Oncology Research Program — Durham, North Carolina, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology, PA - Sammons Cancer Center — Dallas, Texas, United States
• Urology of Virginia, PLLC — Virginia Beach, Virginia, United States
• Virginia Mason Medical Center Urology and Renal Transplantation — Seattle, Washington, United States
• Aurora Advanced Healthcare, Inc — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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