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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00203892 |
The purpose of this study is to determine whether the experimental vaccine "modified CEA peptide CAP 1
Condition | Intervention | Phase |
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Pancreatic Adenocarcinoma |
Drug: Modified CEA (CAP1-6D) Peptide (drug) Drug: CEA Peptide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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III: Experimental
3 dose levels. Arm 3 is 1000mcg.
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Drug: CEA Peptide
every 14 days
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I: Experimental
Arm 1 is 10mcg.
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Drug: Modified CEA (CAP1-6D) Peptide (drug)
Arm 1 is 10mcg arm 2 is 100mcg and arm 3 is 1000mcg
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II: Experimental
Arm 2 is 100mcg.
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Drug: Modified CEA (CAP1-6D) Peptide (drug)
Arm 2 is 100mcg
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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. 1999).
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hedy Kindler, M.D. | 773-702-0360 | hkindler@medicine.bsd.uchicago.edu |
United States, Illinois | |
The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Hedy Kindler, M.D. 773-702-0360 hkindler@medicine.bsd.uchicago.edu | |
Principal Investigator: Hedy Kindler, M.D. |
Principal Investigator: | Hedy Kindler, M.D. | University of Chicago |
Responsible Party: | The University of Chicago ( Hedy Kindler, MD/Principal Investigator ) |
Study ID Numbers: | 12095B |
Study First Received: | September 12, 2005 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00203892 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Adenocarcinoma Pancreas |
Adenocarcinoma Pancrelipase Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |