Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
Recruitment status was: Active, not recruiting
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.
Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
|Study Design:||Masking: 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|
- Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22 [ Designated as safety issue: Yes ]
- Immunogenicity of the peptide mixture by Elispot assay at day 22 [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091286
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Charles M. Friel, MD||University of Virginia|