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An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Colonic Neoplasms, Colorectal Neoplasms

Thank you

Trial Information

An Open Label, Multi-Center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage III Colon Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

EP2101-102

NCT ID:

NCT00054912

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Colonic Neoplasms
  • Colorectal Neoplasms
  • vaccine
  • colon
  • cancer
  • colorectal
  • neoplasm
  • Colonic Cancer
  • Colon Cancer
  • Cancer of the Colon
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

University of Washington Seattle, Washington  98195
Mary Crowley Medical Research Center Dallas, Texas  75246
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Duke University Medical Center Durham, North Carolina  27710
Cancer Centers of Florida Orlando, Florida  32806
University of California, San Diego La Jolla, California  92037-1709
New York Oncology Hematology Albany, New York  12208
University of Southern California School of Medicine Los Angeles, California  90033