To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen
1 other identifier
interventional
122
1 country
12
Brief Summary
This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Oct 2008
Typical duration for phase_2 prostate-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedResults Posted
Study results publicly available
May 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 23, 2017
April 1, 2017
3.5 years
July 11, 2008
February 19, 2014
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.
An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
Baseline, Months 2, 4 and 6.
Study Arms (3)
Cohort A
ACTIVE COMPARATORSipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Cohort B
ACTIVE COMPARATORSipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Cohort C
ACTIVE COMPARATORSipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
- Progressive androgen independent castrate resistant prostate cancer.
- Serum PSA ≥ 5.0 ng/mL.
- Life expectancy of ≥ 6 months.
- Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration.
- Men ≥ 18 years of age.
- Adequate hematologic, renal and liver function.
You may not qualify if:
- 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, malignant pleural effusions, or malignant ascites.
- A requirement for treatment with opioid analgesics for any reason within 21 days prior to registration.
- Moderate to severe disease related pain.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
- Use of non-steroidal antiandrogens within 6 weeks of registration.
- Anti-androgen withdrawal response.
- Treatment with chemotherapy within 3 months of registration.
- More than 2 chemotherapy regimens prior to registration.
- Initiation or discontinuation of bisphosphonate therapy within 28 days prior to registration.
- Treatment with any of the following medications or interventions within 28 days of registration:
- Systemic corticosteroids,
- External beam radiation therapy or surgery,
- Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto,
- Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole,
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (12)
UCSD Moores Cancer Center
La Jolla, California, 92093-0820, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Providence Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
Northwest Cancer Specialists
Portland, Oregon, 97227, United States
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, 23503, United States
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98102, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shabnam Vaziri
- Organization
- Dendreon
Study Officials
- STUDY DIRECTOR
Robert Israel, MD
Valeant Pharmaceuticals North America LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2008
First Posted
July 15, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2012
Study Completion
May 1, 2015
Last Updated
May 23, 2017
Results First Posted
May 12, 2014
Record last verified: 2017-04