Methods: This study will enroll patients with renal cell carcinoma Stage III (T3 N1 M0) or
Stage IV (T4 N0 N1 M0 - any T N2 M0 - any T any N M1) after nephrectomy. Peripheral blood
mononuclear cells collected through leukapheresis are processed for DC generation.
Mononuclear cells are separated and cultured for 7 days in GM-CSF and IL-4. Harvested DC
will be pulsed with renal tumor RNA harvested during nephrectomy. An aliquot of these cells
will be tested for appropriate phenotype fungal and bacterial sterility as well as for
endotoxin content prior to lot release. Renal tumor RNA transfected DC will be stored
cryopreserved until administration.
The first 3 patients will be enrolled at a low dose and monitored for dose limiting
toxicities. If no dose limiting toxicities are seen, the next 3 patients will be enrolled at
the medium dose. If no dose limiting toxicities are seen in the medium dose, 6 additional
patients will be enrolled on the high dose and will be evaluated for dose limiting
toxicities. If in preparation of the vaccine insufficient RNA or dendritic cells are
available to perform the required three injections at the assigned dose level or if the
patient is withdrawn from the study the treatment position will remain open, i.e., no dose
fractions will be given. Patients in whom only the minimum number of DCRCC-RNA can be
produced to deliver one I.V. and one I.D. injection will be able to receive the vaccine,
even if he or she is assigned to a higher dose level, but will be replaced in order to
assess toxicity.
Data Analysis 1. To determine the short and long term toxicities associated with
administration of DCRCC-RNA in patients with metastatic RCC. 2. To determine feasibility of
DC vaccine generation according to the proportion of patients for whom sufficient cells are
generated to provide treatment. 3. To determine the cellular immune response to
administration of DCRCC-RNA. 4. To measure the clinical responses mediated by administration
of DCRCC-RNA.
Interventional
Primary Purpose: Treatment
Johannes Vieweg, M.D.
Principal Investigator
United States: Federal Government
NCRR-M01RR00030-0153
NCT00006431
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |