To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00715078 |
Recruitment Status :
Completed
First Posted : July 15, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 23, 2017
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Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Intervention |
Biological: sipuleucel-T |
Enrollment | 122 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cohort A | Cohort B | Cohort C |
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Sipuleucel-T with the concentration of 10 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. | 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. | 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. |
Period Title: Overall Study | |||
Started | 41 | 40 | 41 |
Received ≥ 1 Study Infusion | 40 | 40 | 39 |
Received ≥ 1 Leukapheresis | 40 | 40 | 40 |
Completed | 11 | 4 | 3 |
Not Completed | 30 | 36 | 38 |
Reason Not Completed | |||
Death | 29 | 36 | 36 |
Withdrawal by Subject | 1 | 0 | 1 |
Unable to start due to disease prog. | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Cohort A | Cohort B | Cohort C | Total | |
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Sipuleucel-T with the concentration of 10 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. | 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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 41 | 40 | 41 | 122 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants | |
<=18 years |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
11 26.8%
|
9 22.5%
|
11 26.8%
|
31 25.4%
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>=65 years |
30 73.2%
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31 77.5%
|
30 73.2%
|
91 74.6%
|
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants | |
71.0 (8.25) | 71.8 (8.29) | 68.6 (7.5) | 70.5 (8.07) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants | |
Female |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Male |
41 100.0%
|
40 100.0%
|
41 100.0%
|
122 100.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
5 12.5%
|
0 0.0%
|
5 4.1%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
3 7.3%
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0 0.0%
|
3 7.3%
|
6 4.9%
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White |
38 92.7%
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35 87.5%
|
38 92.7%
|
111 91.0%
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More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants |
41 100.0%
|
40 100.0%
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41 100.0%
|
122 100.0%
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Eastern Cooperative Oncology Group (ECOG) performance status
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants |
ECOG 0=Fully Active; No restrictions |
29 70.7%
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24 60.0%
|
27 65.9%
|
80 65.6%
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ECOG 1= Restricted Strenuous Activity |
12 29.3%
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16 40.0%
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14 34.1%
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42 34.4%
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[1]
Measure Description: ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
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Gleason Score
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 41 participants | 40 participants | 41 participants | 122 participants |
Gleason Score ≤ 6 |
7 17.1%
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8 20.0%
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4 9.8%
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19 15.6%
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Gleason Score =7 |
12 29.3%
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15 37.5%
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14 34.1%
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41 33.6%
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Gleason Score ≥ 8 |
22 53.7%
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16 40.0%
|
23 56.1%
|
61 50.0%
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Missing information |
0 0.0%
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1 2.5%
|
0 0.0%
|
1 0.8%
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[1]
Measure Description: Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Results Point of Contact
Name/Title: | Shabnam Vaziri |
Organization: | Dendreon |
Phone: | 206-455-2323 |
EMail: | Svaziri@Dendreon.com |
Responsible Party: | Dendreon |
ClinicalTrials.gov Identifier: | NCT00715078 |
Other Study ID Numbers: |
P07-2 |
First Submitted: | July 11, 2008 |
First Posted: | July 15, 2008 |
Results First Submitted: | February 19, 2014 |
Results First Posted: | May 12, 2014 |
Last Update Posted: | May 23, 2017 |