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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Morse, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00103142
First received: February 7, 2005
Last updated: October 11, 2015
Last verified: October 2015
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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 ( Other Identifier: Legacy Duke IRB Number )
CDR000041079 ( Other Identifier: NCI )
Study First Received: February 7, 2005
Results First Received: January 16, 2014
Last Updated: October 11, 2015
Health Authority: United States: Food and Drug Administration