Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor (Phase I/II Study)
This is an uncontrolled, non-randomized trial to evaluate safety, immunogenicity and
feasibility of a new vaccine, consisting of autologous monocyte-derived dendritic cells (DC)
transfected with autologous tumor-derived DNA. Briefly, the plan is to use a two-stage trial
design and to initially enroll 17 patients with primary advanced carcinoma of the oral
cavity or oropharynx 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 DC-based vaccine will contain
DNA-transfected DC. It will be administered intranodally under ultrasound guidance. Only
those patients who have normal delayed type hypersensitivity (DTH) responses to recall
antigens will be eligible to receive the vaccine. Immunologic response to the vaccine will
be evaluated. If there is no evidence of toxicity, and >3 patients show immunologic
response, the second stage of the study will be opened for accrual of 22 patients. All
patients will be monitored by interferon- gamma (IFN-) secretion in enzyme-linked immunospot
(ELISPOT) assays prior to and after vaccination for the frequency of T-cells responsive to
autologous tumor and 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).
Primary Objective: To determine the safety and feasibility of immunization of patients with
carcinoma of the oral cavity or oropharynx with autologous monocyte-derived dendritic cells
(DC) transfected with DNA obtained from the patient's own cancer cells.
Secondary Objective: To evaluate the ability of the DNA-based DC vaccine to induce immune
responses to the vaccine as well as to autologous tumor.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and feasibility of immunization of patients with the carcinomas of the oral cavity or the oropharynx with autologous DCs nucleofected with tumor DNA obtained from the patient's own tumor.
Jonas T Johnson, M.D.
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|