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.
|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|