PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment
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ClinicalTrials.gov Identifier: NCT00694551 |
Recruitment Status :
Completed
First Posted : June 10, 2008
Results First Posted : February 19, 2014
Last Update Posted : October 4, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Prostate Cancer |
Interventions |
Biological: Peptide Vaccine Drug: Poly IC-LC |
Enrollment | 29 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | A. Level 100 mcg Peptide Vaccine | B. Level 300 mcg Peptide Vaccine | C. Level 1 mg Peptide Vaccine |
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Peptide vaccine dose level 100 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Peptide vaccine dose level 300 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Peptide vaccine dose level 1 mg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Period Title: Overall Study | |||
Started | 10 | 10 | 9 |
Completed | 9 | 10 | 8 |
Not Completed | 1 | 0 | 1 |
Reason Not Completed | |||
Disease Progression | 1 | 0 | 1 |
Arm/Group Title | A. Peptide Vaccine | B. Peptide Vaccine | C. Peptide Vaccine | Total | |
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Peptide vaccine dose Level 100 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Peptide vaccine dose level 300 mcg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Peptide vaccine dose level 1 mg Peptide Vaccine: Peptide vaccine (PSMA and TARP peptide vaccine with Poly IC-LC adjuvant). Pilot study using three treatment arms of increasing peptide dose levels (100 mcg, 300 mcg, and 1 mg) with a fixed dose of Poly IC-LC as an adjuvant. Patients were randomly assigned to one of the 3 arms upon enrollment. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 10 | 10 | 9 | 29 | |
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All patients who received any amount of study treatment were considered evaluable for toxicity.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 10 participants | 10 participants | 9 participants | 29 participants | |
69
(56 to 82)
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69.5
(56 to 83)
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69
(58 to 80)
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69.5
(56 to 83)
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | 10 participants | 9 participants | 29 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
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|
Between 18 and 65 years |
1 10.0%
|
6 60.0%
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2 22.2%
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9 31.0%
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>=65 years |
9 90.0%
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4 40.0%
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7 77.8%
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20 69.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 10 participants | 10 participants | 9 participants | 29 participants | |
Female |
10 100.0%
|
10 100.0%
|
9 100.0%
|
29 100.0%
|
|
Male |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 10 participants | 10 participants | 9 participants | 29 participants |
10 | 10 | 9 | 29 |
Name/Title: | Mayer Fishman, M.D., Ph.D. |
Organization: | H. Lee Moffitt Cancer Center and Research Institute |
Phone: | 813-745-4398 |
EMail: | mayer.fishman@moffitt.org |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00694551 |
Other Study ID Numbers: |
MCC-15262 106346 ( Other Identifier: USF IRB ) 20-14555-05-01 ( Other Grant/Funding Number: SPORE in prostate cancer - Pro ) |
First Submitted: | June 4, 2008 |
First Posted: | June 10, 2008 |
Results First Submitted: | January 6, 2014 |
Results First Posted: | February 19, 2014 |
Last Update Posted: | October 4, 2019 |