Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

NCT ID: NCT00901342

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-06-30

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 received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sipuleucel-T

Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Group Type: EXPERIMENTAL

sipuleucel-T

Intervention Type: BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Interventions

sipuleucel-T

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Intervention Type: BIOLOGICAL

Other Intervention Names

• Provenge® • APC8015

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dendreon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Israel, MD

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals North America LLC

Locations

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

Countries

United States

Related Links

http://www.ustoo.org

US TOO International

Other Identifiers

P09-1

Identifier Type: -

Identifier Source: org_study_id