Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer (NSCLC)
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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.
Evaluated for 52 weeks
Edward A Hirschowitz, MD
University of Kentucky
United States: Food and Drug Administration
|University of Louisville Hospital||Louisville, Kentucky 40202|
|Owensboro Medical Health System||Owensboro, Kentucky 42303|
|University of Kentucky||Lexington, Kentucky 40536-0098|
|Commonwealth Cancer Center||Danville, Kentucky 40422|