Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00091286
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : September 9, 2004
Last Update Posted : November 16, 2010
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.

PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with stage IIB, stage III, or stage IV colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine Not Applicable

Detailed Description:


  • Determine whether vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 causes an immune response in patients with stage IIB, III, or IV colorectal cancer.
  • Determine the safety of this regimen in these patients.

OUTLINE: Patients receive vaccination comprising HER-2-neu and carcinoembryonic antigen synthetic peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node into which the vaccination site drains to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 15 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Immunogenicity of Vaccination With HER-2/Neu and CEA Derived Synthetic Peptides With GM-CSF-in-Adjuvant, in Patients With Stage IIB, III, or IV Colorectal Cancer
Study Start Date : March 2003
Estimated Primary Completion Date : April 2011

Primary Outcome Measures :
  1. Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22
  2. Immunogenicity of the peptide mixture by Elispot assay at day 22

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of colorectal cancer

    • Stage IIB, III, or IV disease
  • HLA-A2- or -A3-positive



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,000/mm^3
  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm^3


  • Liver function tests ≤ 2.5 times upper limit of normal (ULN)


  • Creatinine ≤ 1.5 times ULN


  • No New York Heart Association class III or IV heart disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known or suspected allergies to any component of the study drug
  • No active connective tissue disease requiring medications
  • No systemic autoimmune disease with visceral involvement
  • No uncontrolled diabetes
  • No other severe autoimmune disease
  • No medical contraindication or potential problem that would preclude study compliance


Biologic therapy

  • More than 30 days since prior immunotherapy
  • More than 30 days since prior growth factors
  • More than 30 days since prior allergy shots
  • No prior vaccination with any study peptides for malignancy


  • More than 30 days since prior chemotherapy

Endocrine therapy

  • More than 30 days since prior steroids


  • More than 30 days since prior radiotherapy


  • More than 30 days since prior surgery


  • At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer
  • No concurrent illegal drug use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00091286

Layout table for location information
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Charles M. Friel, MD University of Virginia

Layout table for additonal information Identifier: NCT00091286    
Other Study ID Numbers: CDR0000386177
First Posted: September 9, 2004    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: October 2007
Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
stage IIB colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage IVA colon cancer
stage IVB colon cancer
recurrent rectal cancer
stage IIB rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
stage IIIC rectal cancer
stage IVA rectal cancer
stage IVB rectal cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Immunologic Factors
Physiological Effects of Drugs