Active Immunization of Patients With Non Small Cell Lung Cancer (NSCLC) Using Fibroblasts Transfected With DNA From Autologous Tumor (Phase IB Study)
This is an uncontrolled, non-randomized trial to evaluate safety, immunogenicity and
feasibility of a new vaccine, consisting of semi-allogeneic fibroblasts transfected with
autologous tumor-derived DNA. Briefly, the plan is to use a two-stage trial design and to
initially enroll 15 patients with non small cell lung cancer (NSCLC) over a period of 2
years. The patients will undergo surgery and a portion of the primary tumor specimen not
necessary for the pathologic diagnosis will be obtained to serve as a source of tumor DNA.
Each DNA-based vaccine will contain 1 x 10e7 DNA-transfected human allogeneic fibroblasts.
The vaccine will be lethally irradiated before it is used for immunization. It will be
administered intradermally in the Outpatient Clinic. Patients delayed-type hypersensitivity
(DTH) responses will be tested but will not be an eligibility criterion. Immunologic
response to the vaccine will be evaluated. If there is no evidence of toxicity, and >3 of
the 15 initial patients show immunologic response, the second stage of the study will be
opened for accrual of 22 patients. All patients will be monitored by IFN-g secretion in
ELISPOT assays prior to and after vaccination for the frequency of T-cells responsive to
autologous tumor (if available) and/or to the vaccine. The patients will also be evaluated
before and after vaccination for the capability of their T cells to respond to activating
signals delivered via the T cell receptor (TcR).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and feasibility; patients will be observed for treatment-related toxicity during and after each immunization,and for 1 h after immunization in the event that an immediate-type hypersensitivity reaction occurs.
Ahmad Tarhini, MD
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|University of Pittsburgh Cancer Institute - Hillman Cancer Center||Pittsburgh, Pennsylvania 15232|