Clinical trial NCT01338012: Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
Official title: An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: metastatic castrate resistant prostate cancer
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
prostatic adenocarcinoma
Sipuleucel-T
castration resistant prostate cancer (CRPC)
booster
retreatment
immune memory
immune response
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 8
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: Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Detailed description: Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.

Study Objectives:

Primary: Evaluate the immune response generated by sipuleucel-T.

Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.

Eligibility criteria: Inclusion Criteria:

* Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
* Radiologic evidence of metastasis
* Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
* Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration
* Adequate hematologic function

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Treatment with chemotherapy within 3 months prior to registration
* Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
* Treatment with commercial sipuleucel-T (Provenge®)
* Current or imminent pathologic long-bone fracture or spinal cord compression
* Known malignancies other than prostate cancer likely to require treatment within 6 months following 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 antibiotic therapy or causing fever within 1 week prior to registration
* Any surgery requiring general anesthetic within 28 days prior to registration

Primary outcomes:
measure: Number of Study Participants Enrolled and Treated Prior to Study Termination
timeFrame: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange County Urology Associates
state: California
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Seattle
country: United States
facility: Virginia Mason Hospital
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Valeant Pharmaceuticals North America LLC
name: Robert Israel, MD
role: STUDY_DIRECTOR
References: