Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00776295
Recruitment Status : Terminated (Low accrual)
First Posted : October 21, 2008
Results First Posted : June 21, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Small Cell Lung Cancer
Intervention Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title p53 Vaccination
Hide Arm/Group Description Dendritic cell p53 vaccination
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title p53 Vaccination
Hide Arm/Group Description Dendritic cell p53 vaccination
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Subjects Meeting 1-year Overall Survival
Hide Description Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
Time Frame up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title p53 Vaccination
Hide Arm/Group Description:
Dendritic cell p53 vaccination
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title 3 Year Progression-free Survival
Hide Description 3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title p53 Vaccination
Hide Arm/Group Description:
Dendritic cell p53 vaccination
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biological/Vaccine
Hide Arm/Group Description Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes
All-Cause Mortality
Biological/Vaccine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Biological/Vaccine
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Biological/Vaccine
Affected / at Risk (%)
Total   0/2 (0.00%) 
Early termination of trial due to small number of subjects thus leading to unreliabe data
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mohamed Kharfan Dabaja, MD
Organization: H. Lee Moffitt Cancer Center
Phone: 961-1350000 ext 5350
EMail: MK143@aub.edu.lb
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00776295    
Obsolete Identifiers: NCT00609583
Other Study ID Numbers: MCC 14955
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: October 4, 2011
Results First Posted: June 21, 2012
Last Update Posted: January 24, 2013