Clinical trial NCT00901342: Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
Official title: An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Androgen independent prostate cancer (AIPC)
CRPC
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
prostate specific antigen (PSA)
prostatic adenocarcinoma
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
timeFrame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Department of Urology
state: Indiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Greenbelt
country: United States
facility: Hematology Oncology Consultants
state: Maryland
city: Greenbelt
country: United States
facility: Myron I. Murdock MD LLC
state: Maryland
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack
state: New Jersey
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine Department of Urology
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: GU Oncology Research Program
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, PA - Sammons Cancer Center
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center Urology and Renal Transplantation
state: Washington
city: Wauwatosa
country: United States
facility: Aurora Advanced Healthcare, Inc
state: Wisconsin
Study officials:
affiliation: Valeant Pharmaceuticals North America LLC
name: Robert Israel, MD
role: STUDY_DIRECTOR
References: