Study of CAP1-6D in Patients With Locally Advanced or Surgically Resected Pancreatic Adenocarcinoma - Full Text View

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00203892

Purpose

The purpose of this study is to determine whether the experimental vaccine "modified CEA peptide CAP 1 -6D" (mCEA) can produce an immune response in patients with pancreatic cancer who have received chemotherapy and radiation therapy.

Condition	Intervention	Phase
Pancreatic Adenocarcinoma	Drug: Modified CEA (CAP1-6D) Peptide (drug) Drug: CEA Peptide	Phase II

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

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

Further study details as provided by University of Chicago:

Primary Outcome Measures:

To determine the recommended minimal phase II peptide dose required to induce an optimal cytotoxic T lymphocyte (CTL) response. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To define the dose limiting toxicities of immunization with modified CEA (mCEA) peptide. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
III: Experimental 3 dose levels. Arm 3 is 1000mcg.	Drug: CEA Peptide every 14 days
I: Experimental Arm 1 is 10mcg.	Drug: Modified CEA (CAP1-6D) Peptide (drug) Arm 1 is 10mcg arm 2 is 100mcg and arm 3 is 1000mcg
II: Experimental Arm 2 is 100mcg.	Drug: Modified CEA (CAP1-6D) Peptide (drug) Arm 2 is 100mcg

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must express HLA
Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas that expresses CEA either by IHC or serology.

Patients must have completely resected disease or unresectable locally advanced disease.

Patients with resected disease who had a pancreaticoduodenectomy with negative margins.
Patients with locally advanced disease
Patients must have completed 5FU based chemoradiation>4 weeks, but no more than 12 weeks prior to study registration.
Age >18 years.
ECOG performance status 0-1
Life expectancy greater than 6 months
Patients must have normal organ and marrow function
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients who have had chemotherapy, biologic therapy, radiotherapy, or an experimental (investigational) agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not have received a previous CEA vaccine.
Patients with known metastatic disease
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CEA, Montanide ISA-51, or GM-CSF.
Patients must not have known autoimmune disorders (SLE, Rheumatoid Arthritis), conditions of immunosuppression (such as HIV), or treatment with immunosuppressive drugs (including oral steroids, continuous use of topical steroids, steroid inhalers). Replacement doses of steroids for patients with adrenal insufficiency are allowed.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active GI bleeding, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breast-feeding women
HIV-positive patients
Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203892

Contacts

Contact: Hedy Kindler, M.D.

773-702-0360

hkindler@medicine.bsd.uchicago.edu

Locations

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.

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Hedy Kindler, M.D.

University of Chicago

More Information

Responsible Party:	The University of Chicago ( Hedy Kindler, MD/Principal Investigator )
Study ID Numbers:	12095B
Study First Received:	September 12, 2005
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00203892
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

Adenocarcinoma
Pancreas

Study placed in the following topic categories:

Adenocarcinoma
Pancrelipase
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009