Prostate CancerPhase 2NCT00715078
To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
A Phase 2 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- sipuleucel-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2008to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.
- Men ≥ 18 years of age.
- Adequate hematologic, renal and liver function.
Who cannot join
- 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.
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- 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,
- 5-alpha-reductase inhibitors,
- High dose calcitriol [1,25(OH)2Vitamin D] (i.e., > 0.5 mcg/day).
- Any other systemic therapy for prostate cancer (except for medical castration).
- Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
- Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
- Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
- A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time 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 > 100.5°F or > 38.1°C) 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Indiana University
Indianapolis, Indiana, 46202
UCSD Moores Cancer Center
La Jolla, California, 92093-0820
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, 23503
Providence Medical Center
Portland, Oregon, 97213
Kaiser Permanente
Portland, Oregon, 97227
Northwest Cancer Specialists
Portland, Oregon, 97227
Sharp Clinical Oncology Research
San Diego, California, 92123
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, 98101
Seattle Cancer Care Alliance
Seattle, Washington, 98102
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
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
Read the detailed description
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 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
- Conditions
- Prostate Cancer
- Being tested
- sipuleucel-T
- Keywords
- prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells, cancer vaccine, prostate specific antigen (PSA), prostatic adenocarcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipuleucel-TBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Active comparator | Sipuleucel-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. Receives: Biological: sipuleucel-T |
| Cohort B | Active comparator | Sipuleucel-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. Receives: Biological: sipuleucel-T |
| Cohort C | Active comparator | Sipuleucel-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. Receives: Biological: sipuleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Months 2, 4 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Israel, MD, Study director, Valeant Pharmaceuticals North America LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715078
- Sponsor's protocol ID
- P07-2
- Status last verified
- Apr 2017
- First submitted
- 11 Jul 2008
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00715078
- Acronym / sponsor ID
- P07-2
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, antigen-presenting cells, antigen presenting cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 12 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Active comparator | Biological: sipuleucel-TSipuleucel-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 comparator | Biological: sipuleucel-TSipuleucel-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 comparator | Biological: sipuleucel-TSipuleucel-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sipuleucel-TSipuleucel-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) | Biological | Cohort A, Cohort B, Cohort C |
Primary outcome
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.
Time frame: Baseline, Months 2, 4 and 6.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Prostate Cancer Research InstituteLink provided by the sponsor.
- National Alliance of State Prostate Cancer CoalitionsLink provided by the sponsor.
- Us TOO InternationalLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Israel, MD study director
Valeant Pharmaceuticals North America LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sipuleucel-T in people with Prostate Cancer, run by Dendreon at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. (time frame: Baseline, Months 2, 4 and 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.