An Open Label Study of a Peptide Vaccine in Patients With Stage III Colon Cancer

NCT ID: NCT00054912

Last Updated: 2008-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Colon Cancer.

Detailed Description

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Conditions

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Colonic Neoplasms Colorectal Neoplasms

Keywords

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vaccine colon cancer colorectal neoplasm Colonic Cancer Colon Cancer Cancer of the Colon

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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EP2101

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of Colon Cancer, stage III
* At least four weeks following prior standard treatment, with no evidence of disease
* Must use adequate birth control

Exclusion Criteria

* Prior cancer vaccine therapy or concurrent participation in any other investigational study
* A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
* A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
* Women who are pregnant, intend to become pregnant, or who are breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epimmune

INDUSTRY

Sponsor Role lead

Locations

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University of Southern California School of Medicine

Los Angeles, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Cancer Centers of Florida

Orlando, Florida, United States

Site Status

New York Oncology Hematology

Albany, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Cancer Care Northwest

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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EP2101-102

Identifier Type: -

Identifier Source: org_study_id