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Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF and PEG-INTRON(R)

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ClinicalTrials.gov Identifier: NCT00415857
Recruitment Status : Terminated (Vaccine sponsor ceased operations.)
First Posted : December 25, 2006
Results First Posted : April 30, 2014
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
The Vaccine Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Biological: Peptide Vaccine (PR1 Peptide)
Drug: Peginterferon alfa-2b
Drug: Imatinib
Drug: GM-CSF

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: December 20, 2006 to March 13, 2009. All recruitment done at the University of Texas (UT) MD Anderson Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to the unavailability of the study drug (vaccine) enrollment was halted and the study eventually terminated when additional attempts were unsuccessful to obtain a supply of vaccine.

Reporting Groups
  Description
PR1 + Imatinib PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
PR1 + Imatinib + Interferon PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.

Participant Flow:   Overall Study
    PR1 + Imatinib   PR1 + Imatinib + Interferon
STARTED   2   3 
COMPLETED   2   3 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
PR1 + Imatinib PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
PR1 + Imatinib + Interferon PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
Total Total of all reporting groups

Baseline Measures
   PR1 + Imatinib   PR1 + Imatinib + Interferon   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   3   5 
Age 
[Units: Years]
Median (Full Range)
 45 
 (35 to 55) 
 46 
 (29 to 50) 
 46 
 (29 to 55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  50.0%      1  33.3%      2  40.0% 
Male      1  50.0%      2  66.7%      3  60.0% 
Region of Enrollment 
[Units: Participants]
     
United States   2   3   5 


  Outcome Measures

1.  Primary:   Molecular Response Rate   [ Time Frame: Baseline to 18 weeks, up to 6 months post final vaccination for overall study participation period. ]

2.  Secondary:   Number of Participants With Immunologic Response   [ Time Frame: Period of 18 weeks (i.e., one vaccination each on weeks 0, 3, 6, and 18). ]


  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: Jorge Cortes M.D./Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/792-7305
e-mail: eharrison@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00415857     History of Changes
Other Study ID Numbers: 2006-0360
First Submitted: December 22, 2006
First Posted: December 25, 2006
Results First Submitted: March 28, 2014
Results First Posted: April 30, 2014
Last Update Posted: August 21, 2018