A Randomized Pilot Phase II Study of Immunization With Modified CEA (CAP1-6D) Peptide In Patients With Locally Advanced Or Surgically Resected Adenocarcinoma of the Pancreas
PC has a dismal prognosis. Despite surgery, chemotherapy, and radiation, most patients with
PC will die of distant metastatic disease. Peptide vaccine approaches offer an attractive
potential treatment option.
Since CEA is expressed in >90% of PC, it would make an attractive target for a vaccination
approach. Several different vaccination approaches have been tested using CEA as a TAA.
Although some investigators suggest that DC-based approaches are the most active, they are
limited by the need to obtain patient-specific DCs. One attractive approach would be to add
GM-CSF to the peptide to recruit endogenous DC to the site of vaccination.
There are data on the use of tumor vaccines in advanced PC. Gjerertsen et al. used a K Ras
peptide and GM-CSF in 48 patients with advanced PC. 50% of patients showed a peptide
specific CTL response (Gjertsen, Buanes et al. 2001). Those that had an immune response had
an increased overall survival, The data from phase I and II clinical trials was based on
heavily pretreated patients with metastatic disease. The majority of clinical responses have
been disease stabilization. The data in B cell lymphoma vaccines suggests that immune
responses are more likely to be generated in minimum disease states (Bendandi, Gocke et al.
For patients that have had a complete resection and treatment with adjuvant chemoradiation,
and for patients with locally advanced nonresectable disease treated with standard
chemoradiation, there is presently no therapy available to decrease the chance of disease
reoccurrence. Our hypothesis is that immunization with a modified CEA peptide in
Montanide/GM-CSF can lead to expansion of CEA-reactive CTL and result in control of CEA
expressing pancreatic carcinomas.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the recommended minimal phase II peptide dose required to induce an optimal cytotoxic T lymphocyte (CTL) response.
Hedy Kindler, M.D.
University of Chicago
United States: Food and Drug Administration
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