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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 : August 8, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A. Level 100 mcg Peptide Vaccine

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.

B. Level 300 mcg Peptide Vaccine

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.

C. Level 1 mg Peptide Vaccine

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.


Participant Flow:   Overall Study
    A. Level 100 mcg Peptide Vaccine   B. Level 300 mcg Peptide Vaccine   C. Level 1 mg Peptide Vaccine
STARTED   10   10   9 
COMPLETED   9   10   8 
NOT COMPLETED   1   0   1 
Disease Progression                1                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who received any amount of study treatment were considered evaluable for toxicity.

Reporting Groups
  Description
A. Peptide Vaccine

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.

B. Peptide Vaccine

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.

C. Peptide Vaccine

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 Total of all reporting groups

Baseline Measures
   A. Peptide Vaccine   B. Peptide Vaccine   C. Peptide Vaccine   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   9   29 
Age 
[Units: Years]
Median (Full Range)
 69 
 (56 to 82) 
 69.5 
 (56 to 83) 
 69 
 (58 to 80) 
 69.5 
 (56 to 83) 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   10   10   9   29 


  Outcome Measures

1.  Primary:   Occurrence of Related Adverse Events - Grade 3 or Higher   [ Time Frame: Up to 48 months ]

2.  Secondary:   Number of Participants With Prostatic Specific Antigen (PSA) Doubling   [ Time Frame: Up to 48 months ]

3.  Secondary:   Number of Participants Who Did Not Have PSA Doubling   [ Time Frame: Up to 48 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mayer.fishman@moffitt.org



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: August 8, 2018