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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 : Active, not recruiting
First Posted : June 10, 2008
Results First Posted : February 19, 2014
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
All patients who received any amount of study treatment were considered evaluable for toxicity.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 9 participants 29 participants
69
(56 to 82)
69.5
(56 to 83)
69
(58 to 80)
69.5
(56 to 83)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 9 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
6
  60.0%
2
  22.2%
9
  31.0%
>=65 years
9
  90.0%
4
  40.0%
7
  77.8%
20
  69.0%
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%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 9 participants 29 participants
10 10 9 29
1.Primary Outcome
Title Occurrence of Related Adverse Events - Grade 3 or Higher
Hide Description Number of participants with related Grade 3 or higher adverse events. Establish the safety and toxicity of varying doses of polypeptide vaccines PSMA and TARP administered with a fixed dose of Poly IC-LC as an adjuvant.
Time Frame Up to 48 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received treatment.
Arm/Group Title A. Level 100 mcg Peptide Vaccine B. Level 300 mcg Peptide Vaccine C. Level 1 mg Peptide Vaccine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10 10 9
Measure Type: Number
Unit of Measure: participants
0 0 0
2.Secondary Outcome
Title Number of Participants With Prostatic Specific Antigen (PSA) Doubling
Hide Description

Number of Participants Who Had a Doubling of the PSA or Proceeded to Another Therapy.

Assess the impact of the vaccine on the pattern of PSA change in patients with castrate testosterone level and in patients with non-suppressed testosterone level not on hormone therapy.

Time Frame Up to 48 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
29 patients who had serial PSA data, normalized by date and PSA.
Arm/Group Title A. Level 100 mcg Peptide Vaccine B. Level 300 mcg Peptide Vaccine C. Level 1 mg Peptide Vaccine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10 10 9
Measure Type: Number
Unit of Measure: participants
8 6 5
3.Secondary Outcome
Title Number of Participants Who Did Not Have PSA Doubling
Hide Description Number of participants who did not have a PSA doubling before their last study visit, median 458 days from baseline PSA (55-613).
Time Frame Up to 48 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
29 patients who had serial PSA data, normalized by date and PSA.
Arm/Group Title A. Level 100 mcg Peptide Vaccine B. Level 300 mcg Peptide Vaccine C. Level 1 mg Peptide Vaccine
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 10 10 9
Measure Type: Number
Unit of Measure: participants
2 4 4
Time Frame 2 years, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A. Peptide Vaccine B. Peptide Vaccine C. Peptide Vaccine
Hide Arm/Group Description

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.

All-Cause Mortality
A. Peptide Vaccine B. Peptide Vaccine C. Peptide Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A. Peptide Vaccine B. Peptide Vaccine C. Peptide Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)      0/9 (0.00%)    
Respiratory, thoracic and mediastinal disorders       
Cough - Grade 2 -  1 [1]  0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
PSMA: Unrelated
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A. Peptide Vaccine B. Peptide Vaccine C. Peptide Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)      9/9 (100.00%)    
Blood and lymphatic system disorders       
Lymphatics - Other  1  0/10 (0.00%)  0 3/10 (30.00%)  3 1/9 (11.11%)  2
Endocrine disorders       
Hot flashes/flushes  1  2/10 (20.00%)  2 1/10 (10.00%)  1 0/9 (0.00%)  0
Gastrointestinal disorders       
Anorexia  1  2/10 (20.00%)  3 0/10 (0.00%)  0 2/9 (22.22%)  3
Nausea  1  2/10 (20.00%)  4 0/10 (0.00%)  0 1/9 (11.11%)  2
General disorders       
Fatigue  1  5/10 (50.00%)  24 5/10 (50.00%)  15 6/9 (66.67%)  29
Feverr (in the absence of neutropenia)  1  6/10 (60.00%)  17 5/10 (50.00%)  22 4/9 (44.44%)  6
Rigors/chills  1  4/10 (40.00%)  10 6/10 (60.00%)  18 2/9 (22.22%)  2
Pain - Head/headache  1  3/10 (30.00%)  15 6/10 (60.00%)  29 7/9 (77.78%)  22
Pain - Muscle  1  4/10 (40.00%)  11 4/10 (40.00%)  19 4/9 (44.44%)  14
Pain - Back  1  0/10 (0.00%)  0 2/10 (20.00%)  2 3/9 (33.33%)  3
Pain - Joint  1  3/10 (30.00%)  3 1/10 (10.00%)  2 0/9 (0.00%)  0
Pain - Neck  1  0/10 (0.00%)  0 2/10 (20.00%)  2 1/9 (11.11%)  2
Flu-like syndrome  1  2/10 (20.00%)  5 1/10 (10.00%)  1 4/9 (44.44%)  8
Musculoskeletal and connective tissue disorders       
Musculoskeletal/Soft Tissue - Other  1  1/10 (10.00%)  1 2/10 (20.00%)  0/9 (0.00%)  0
Nervous system disorders       
Dizziness  1  2/10 (20.00%)  4 3/10 (30.00%)  9 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pulmonary/Upper Respiratory - Other  1  0/10 (0.00%)  0 2/10 (20.00%)  2 4/9 (44.44%)  9
Skin and subcutaneous tissue disorders       
Injection site reaction/extravasation changes  1  7/10 (70.00%)  34 9/10 (90.00%)  46 7/9 (77.78%)  38
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mayer Fishman, M.D., Ph.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-4398
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00694551     History of Changes
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: December 4, 2018