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Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00103116
First Posted: February 8, 2005
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Hirschowitz, University of Kentucky
Results First Submitted: November 7, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Biological: autologous dendritic cell cancer vaccine

  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
Non-randomized open label; stage I-IIIB NSCLC. Closed to accrual in 2006 when defined phase I immunological endpoints were reached.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None excluded; all completed.

Reporting Groups
  Description
Vaccine therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.

Participant Flow:   Overall Study
    Vaccine
STARTED   32 
COMPLETED   32 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Vaccine therapeutic autologous dendritic cells : Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.

Baseline Measures
   Vaccine 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      30  93.8% 
>=65 years      2   6.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20  62.5% 
Male      12  37.5% 
Region of Enrollment 
[Units: Participants]
 
United States   31 
Israel   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization   [ Time Frame: six months post vaccine ]

2.  Secondary:   Number of Participants Alive Five Years Post Vaccine   [ Time Frame: five years post vaccine ]


  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: Edward Hirschowitz
Organization: UKentucky
phone: 8596081981
e-mail: eahirs2@uky.edu


Publications of Results:

Responsible Party: Edward Hirschowitz, University of Kentucky
ClinicalTrials.gov Identifier: NCT00103116     History of Changes
Other Study ID Numbers: CDR0000410830
R21CA091624 ( U.S. NIH Grant/Contract )
UKMC-IRB-0391-F2R ( Other Identifier: IRB )
UKMC-CTRF-G-01-009 ( Other Grant/Funding Number: Cancer Treatment Research Foundation )
First Submitted: February 7, 2005
First Posted: February 8, 2005
Results First Submitted: November 7, 2013
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017