At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 23 enrolled

Drug / intervention

modified CEA peptide (10mcg) +2 morebiological

Likely dose

Modified CEA peptide 10 mcg, 100 mcg, or 1000 mcg with Montanide ISA-51 and GM-CSF 250 mcg, administered on Day 1 of each 14-day cycle for up to 24 cyclesAI-extracted

Key inclusion· 8

✓Histologically or cytologically confirmed pancreatic adenocarcinoma expressing CEA by IHC or serology
✓HLA-A2 expression required
✓Completely resected disease with negative margins OR unresectable locally advanced disease
✓Completed 5FU-based chemoradiation >4 weeks but no more than 12 weeks prior to registration

Key exclusion· 9

✕Prior CEA vaccine
✕Chemotherapy, biologic, radiotherapy, or experimental agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start; unrecovered adverse events from prior agents
✕Known autoimmune disorders (SLE, Rheumatoid Arthritis)
✕Immunosuppression or immunosuppressive drugs including oral steroids, continuous topical steroids, or steroid inhalers (except replacement doses for adrenal insufficiency)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00203892

NCT00203892Phase 2Completed

Compare CT.gov

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

University of Chicago·interventional·Posted Sep 20, 2005·Updated Apr 16, 2014

In Brief

A Phase 2 clinical trial evaluating modified CEA peptide (10mcg), modified CEA peptide (100mcg), and 1 other intervention for Pancreatic Adenocarcinoma. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPancreatic Adenocarcinoma

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2003

First PostedSep 2005

Primary CompletionJun 2009

Study CompletionMay 2012

TodayJul 2026

First PostedSep 20, 2005

Enrollment StartApr 1, 2003

Primary CompletionJun 1, 2009

Study CompletionMay 1, 2012

TodayJul 2, 2026

Enrollment to primary: 6.2 yearsPosted 20.8 years ago

Interventions

modified CEA peptide (10mcg)biological

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.

modified CEA peptide (100mcg)biological

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.

modified CEA peptide (1000mcg)biological

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.