Allogeneic Cellular Vaccine 1650-G for Non-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: NCT00654030|
Recruitment Status : Completed
First Posted : April 7, 2008
Results First Posted : May 20, 2013
Last Update Posted : April 9, 2018
Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.
The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: 1650-G Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: 1650-G Vaccine
Patients receive 2 injections of 1650-G Vaccine given 4 weeks apart, for a total of 52 weeks on study.
Drug: 1650-G Vaccine
.6ml injection administered intradermally in the thigh at week 0 and week 4
Other Name: 1650-G Allogeneic Cellular Vaccine
- Number of Participants Responding to the Vaccine [ Time Frame: 16 weeks after vaccination ]The endpoint is immunologic response measured by IFN-ELISPOT. It will be reported as the percent of patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine). The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654030
|United States, Kentucky|
|Commonwealth Cancer Center|
|Danville, Kentucky, United States, 40422|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Owensboro Medical Health System|
|Owensboro, Kentucky, United States, 42303|
|Study Chair:||Edward A Hirschowitz, MD||University of Kentucky|
|Study Chair:||John R Yannelli, PhD||University of Kentucky|
|Principal Investigator:||Goetz H Kloecker, MD||University of Louisville|
|Principal Investigator:||Thomas R Baeker, MD||Commonwealth Cancer Center|
|Principal Investigator:||Dattatraya S Prajapati, MD||Owensboro Medical Health System|