Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)|
- Primary Outcome Measure: Immunological Response; Antigen Specific Reactions Will be Measured by IFN-ELISPOT. The ELISPOT is a Quantitative Readout of Number of T Cells That React to Specific Antigenic Stimulus. [ Time Frame: Evaluated for 52 weeks ] [ Designated as safety issue: No ]The endpoint is immunologic response measured by IFN-ELISPOT. Increases above pre-vaccine levels (& controls) can be assessed statistically by ANOVA. Percent patients responding to vaccine (>2 Standard Deviation increase from baseline levels pre-vaccine) as well as magnitude of responses (relative ELISPOT measures) will be compared to results obtained using DC/1650 vaccine. The number of individuals responding (> 2 SD change from baseline vaccine) will provide an approximation of biologic efficacy of the vaccine.
|Study Start Date:||October 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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
The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.
Please refer to this study by its ClinicalTrials.gov identifier: 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|