Active Immunization of Patients With Carcinoma of Oral Cavity or Oropharynx With Autologous Dendritic Cells Transfected With DNA From Autologous Tumor
|Primary Advanced Carcinoma of the Oral Cavity or Oropharynx Squamous Cell Carcinoma of the Head and Neck||Biological: autologous monocyte-derived dendritic cells (DC) transfected with DNA||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- 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. [ Time Frame: 6 months ]
- To determine whether the immunological responses to the vaccine and/or antitumor immune responses can be induced in patients who receive the vaccine [ Time Frame: 6 months ]
|Study Start Date:||April 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Experimental: Dendritic Cells w/Tumor DNA||
Biological: autologous monocyte-derived dendritic cells (DC) transfected with DNA
The patients will receive 1 x 107 DC/vaccine delivered intranodally or perinodally to lymph nodes (LN) distant from the head and neck area (e.g., to inguinal LN)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377247
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Jonas T Johnson, M.D.||UMPC/UPCI|