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Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line Chemotherapy

This study has been terminated.
(Per request of Principal Investigator this study was closed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00534209
First Posted: September 24, 2007
Last Update Posted: October 16, 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.
Information provided by (Responsible Party):
University of Miami
Results First Submitted: January 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Biological: Allogeneic B7.1/HLA-A1
Other: Placebo

  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
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
Arm I

Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.

Given intradermally.


Participant Flow:   Overall Study
    Arm I
STARTED   1 
COMPLETED   1 
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
Arm I

Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.

Given intradermally.


Baseline Measures
   Arm I 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 


  Outcome Measures
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1.  Primary:   Preliminary Safety Profile (Phase 1)   [ Time Frame: Up to 13 weeks ]

2.  Primary:   Progression-free Survival (Phase 2)   [ Time Frame: Date of randomization to the earliest date of documented progression. ]

3.  Secondary:   Immune Response (CD8) in B7-vaccinated Participants as Compared to Controls. (Phase 2)   [ Time Frame: About 13 weeks ]

4.  Secondary:   Relationship of CD8 Response in B7-vaccinated Patients to Their Progression-free Survival.(Phase 2)   [ Time Frame: From Week 1 of Study Therapy until Death or Withdrawal of Consent ]

5.  Secondary:   Safety Profile (Phase 2)   [ Time Frame: About 13 weeks ]

6.  Secondary:   Response to Second-line Chemotherapy After Disease Progression (Phase 2)   [ Time Frame: From Week 1 of Study Therapy until Death or Withdrawal of Consent ]

7.  Secondary:   Overall Survival (Phase 2)   [ Time Frame: Date of randomization to the recorded date of death ]

8.  Secondary:   Correlative Immunological Studies in Study Participants (Phase 2)   [ Time Frame: Baseline, Week 7 and Week 13 ]


  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
Study closed early due to low enrollment. A minimum of 2 patients were required for Phase 1, however, this requirement was not met.


  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: Luis Raez MD
Organization: UM/Sylvester Comprehensive Cancer Center
phone: 305-243-4909
e-mail: lraez@med.miami.edu


Publications:

Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00534209     History of Changes
Other Study ID Numbers: 20057158
SCCC-2005042 ( Other Identifier: UM/Sylvester Comprehensive Cancer Center )
WIRB-20051678 ( Other Identifier: Western IRB (WIRB) )
First Submitted: September 20, 2007
First Posted: September 24, 2007
Results First Submitted: January 17, 2013
Results First Posted: February 20, 2013
Last Update Posted: October 16, 2017