Vaccine Therapy in Treating Patients With Stage IIIB or Stage 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:
Collaborator:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00534209
First received: September 20, 2007
Last updated: August 13, 2013
Last verified: August 2013
Results First Received: January 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Biological: Allogeneic B7.1/HLA-A1 transfected tumor cell vaccine
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  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     0  
Male     1  



  Outcome Measures

1.  Primary:   Preliminary Safety Profile (Phase I)   [ Time Frame: 12 weeks ]

2.  Primary:   Progression-free Survival (Phase II)   [ Time Frame: Date of randomization to the earliest date of documented progression. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Clinical Outcomes (Phase I)   [ Time Frame: Summarized by the median and range of follow up time for patients grouped according to disease status (progression/no progression) and vital status (died/alive at last contact). ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Adaptive Immune Response   [ Time Frame: Reported for measurements taken immediately prior to vaccination (week 0) and throughout the two courses. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Safety Profile (Phase II)   [ Time Frame: The number of patients experiencing toxicity over the course of treatment will be characterized by type of toxicity and grade, and by the time of toxicity onset in relation to day of vaccination. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Response to Second-line Chemotherapy After Disease Progression (Phase II)   [ Time Frame: TThe percentage of patients experiencing a clinical response (CR, PR, SD) on second-line chemotherapy will be characterized for B7-vaccinated patients and controls. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Overall Survival (Phase II)   [ Time Frame: Date of randomization to the recorded date of death ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


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


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
Study closed early due to low enrollment. A minimum of 2 patients were required for Phase 1. Only 1 patient enrolled.  


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 Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00534209     History of Changes
Other Study ID Numbers: UMIAMI-20057158, SCCC-2005042, WIRB-20051678
Study First Received: September 20, 2007
Results First Received: January 17, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration