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

NCT00203892 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-04-16

Study results available
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Summary

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.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

BIOLOGICAL

modified CEA peptide (10mcg)

Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.

BIOLOGICAL

modified CEA peptide (100mcg)

Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.

BIOLOGICAL

modified CEA peptide (1000mcg)

Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Hedy Kindler, M.D. · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2009-06-30
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00203892 on ClinicalTrials.gov