Head and Neck Squamous Cell Carcinoma (HNSCC) Clinical Trial
Official title:
Active Immunization of Patients With Head and Neck Squamous Cell Carcinoma (HNSCC) Using Fibroblasts Transfected With DNA From Autologous Tumor
Hypothesis The incidence of toxicity in patients receiving the tumor DNA-transfected
fibroblast vaccine will be acceptably low and the immunologic response rate sufficiently high
to warrant further study of this therapy
The study of the vaccine will proceed in two stages after the method of Simon (102). In the
first stage, 15 patients will be accrued and treated. If two or fewer objective immunologic
responses occur, the study will be terminated. If 3 or more responses are observed, the study
will proceed to the second stage, accruing an additional 22 patients. If the second stage is
complete and a total of 9 or more immunologic responses are observed among the 37 patients
treated, the treatment response rate for the vaccine will be considered high enough to
warrant further study. Conversely, if the evaluation of the vaccine concludes at the first
stage, or if 8 or fewer total immunologic responses occur after completing the second stage,
the vaccine will not be considered for further study.
This is a single institution open-label phase Ib clinical trial designed to determine the
safety of immunization of patients with resected Head and Neck Squamous Cell Carcinoma
(HNSCC) with lethally irradiated semi-allogeneic human fibroblasts (MRC-5) transfected with
DNA derived from the subject's own tumor and to measure the immune response to the autologous
tumor vaccine.
Briefly, the plan is to use a two-stage trial design and to initially enroll 15 patients with
Head and Neck Squamous Cell Carcinoma (HNSCC). The patients will undergo surgical resection
to provide complete removal of the primary lesion with negative gross and microscopic
margins. A portion of the primary tumor specimen not necessary for the pathologic diagnosis
will be obtained to serve as a source of DNA for preparing the vaccine. 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 for a total of four vaccinations delivered at weekly
intervals.
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.
To determine patient's response to the DNA-based vaccines, the frequency of T cells reactive
with recipient cells transfected with the autologous tumor DNA will be measured by ELISPOT
for IFN-y and compared with the response to non-transfected fibroblasts prior to and after
vaccination. All patients will be monitored for Immunologic response by assays include
ELISPOT, flow cytometry for lymphocyte markers, Annexin V binding, TcR expression, caspase3
activity and serum antibodies.
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