Expired Study
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Chicago, Illinois 60637


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients must express HLA-A2 - Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas that expresses CEA either by IHC or serology. - Patients prior chemotherapy must have been completed at least 28 days prior to the start of treatment 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 or metastatic 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 3 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. - 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 are excluded from this study because peptide vaccines and/or GM-CSF have an unknown effect on a fetus. Breastfeeding should be discontinued if the mother is gong to be treated on this clinical trial. - Because the risk to patients with immune deficiency treated with peptide vaccine is unknown, HIV-positive patients are excluded from the study. Appropriate studies will be undertaken in patients with intrinsic immunosuppression when indicated. - Patients with a currently active second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and have no evidence of recurrence for at least 5 years


Study is Available At:


Original ID:

12095B


NCT ID:

NCT00203892


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Hedy Kindler, M.D.
Principal Investigator
University of Chicago

Study Dates

Start Date:April 2003
Completion Date:June 2014
Completion Type:Anticipated
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:September 2012
Last Changed Date:September 11, 2012
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To define the dose limiting toxicities of immunization with modified CEA (mCEA) peptide.
Time Frame:14 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine the recommended minimal phase II peptide dose required to induce an optimal cytotoxic T lymphocyte (CTL) response.
Time Frame:14 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Modified CEA (CAP1-6D) Peptide (drug)
Description:Arm 1 is 10mcg arm 2 is 100mcg and arm 3 is 1000mcg
Arm Name:I
Other Name:CEA Peptide
Intervention Type:Drug
Name:CEA Peptide
Description:every 14 days
Arm Name:III
Intervention Type:Drug
Name:Modified CEA (CAP1-6D) Peptide (drug)
Description:Arm 2 is 100mcg
Arm Name:II

Study Arms

Study Arm Type:Experimental
Arm Name:III
Description:3 dose levels. Arm 3 is 1000mcg.
Study Arm Type:Experimental
Arm Name:I
Description:Arm 1 is 10mcg.
Study Arm Type:Experimental
Arm Name:II
Description:Arm 2 is 100mcg.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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