Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Morse, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00103142
First received: February 7, 2005
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: January 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Metastatic Cancer
Interventions: Biological: falimarev
Biological: inalimarev
Biological: sargramostim
Biological: therapeutic autologous dendritic cells

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a 7 site study where patients were recruited from medical clinics and the patient’s primary oncologist and study team approached the patient about the study. Patients were recruited for this study from January 2005 and September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was designed to treat 72 subjects. Total number of enrollment is 74 because enrollment reflects the number of subjects that signed consent and were randomized to the study but did not necessarily receive study drug or complete study drug.

Reporting Groups
  Description
PANVAC-V + PANVAC-F + DC Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
PANVAC-V + PANVAC-F + GM-CSF Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.

Participant Flow:   Overall Study
    PANVAC-V + PANVAC-F + DC     PANVAC-V + PANVAC-F + GM-CSF  
STARTED     36     37  
COMPLETED     33     36  
NOT COMPLETED     3     1  
Adverse Event                 1                 0  
Progression of disease                 2                 1  



  Baseline Characteristics
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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.
37 PANVAC-V + PANVAC-F + DC arm patients and 37 PANVAC-V + PANVAC-F + GM-CSF arm. One participant in PANVAC-V + PANVAC-F + DC Arm was consented and contributed baseline data, but was not considered to have started or enrolled in the study patients signed consent.

Reporting Groups
  Description
Experimental PANVAC-V + PANVAC-F + DC Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
Experimental PANVAC-V + PANVAC-F + GM-CSF Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
Total Total of all reporting groups

Baseline Measures
    Experimental PANVAC-V + PANVAC-F + DC     Experimental PANVAC-V + PANVAC-F + GM-CSF     Total  
Number of Participants  
[units: participants]
  37     37     74  
Age  
[units: years]
Median ( Full Range )
  53.6  
  ( 25 to 77 )  
  52.0  
  ( 33 to 74 )  
  53.5  
  ( 25 to 77 )  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     30     58  
>=65 years     9     7     16  
Gender  
[units: participants]
     
Female     21     18     39  
Male     16     19     35  
Region of Enrollment  
[units: participants]
     
United States     37     37     74  
Sites of metastasis  
[units: participants]
     
Liver     26     31     57  
Lung     11     6     17  
Number of nodules  
[units: participants]
     
1 nodules     11     17     28  
2-4 nodules     16     12     28  
>4 nodules     4     5     9  
unknown     6     3     9  
Carcinoembryonic antigen (CEA)  
[units: mcg/L]
Mean ( Full Range )
  2.0  
  ( 0.6 to 13.0 )  
  1.8  
  ( 0.5 to 15.0 )  
  1.9  
  ( 0.5 to 15.0 )  



  Outcome Measures
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1.  Primary:   Recurrence-free Survival at 2 Years   [ Time Frame: 2 years ]

2.  Secondary:   Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay   [ Time Frame: 13 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Morse
Organization: Duke University Medical Center
phone: 919-684-5705
e-mail: michael.morse@dm.duke.edu


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Michael Morse, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00103142     History of Changes
Other Study ID Numbers: Pro00007616, DUMC-5883-04-6RO, CDR000041079
Study First Received: February 7, 2005
Results First Received: January 16, 2014
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration