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Therapeutic Areas: Oncology | Gastroenterology
Disease Category: Colon Cancer

Trial Information

Evaluation of the Immunogenicity of Vaccination with Her-2/neu and CEA derived Synthetic Peptides with GM-CSF-in-Adjuvant, in Patients with Resected Stage IIB or III Abdominal Colon Cancer HIC# 9976

This is an open-label, pilot study of a vaccine comprising class I MHC-restricted Her-2/neu and CEA derived peptides, and a class II MHC-restricted tetanus helper peptide, administered in GM-CSF-in-adjuvant.

Regimen:
Each vaccination will be administered over a 3-week period (days 1, 8, and 15).

All patients will receive 4 class I MHC-restricted synthetic peptides (2 each restricted by HLA-A2, and two restricted by HLA - A3) and a class II MHC-restricted tetanus helper peptide.

All vaccines will contain GM-CSF-in-adjuvant and will be administered intradermally and subcutaneously. For each vaccination, patients will be vaccinated at two different sites, the vaccination site and in a distal replicate vaccination site. The immunologic response to the vaccine will be evaluated at the lymph node draining the replicate vaccination site. This node will be harvested using lymphatic mapping and sentinel node biopsy methods and will be referred to as the sentinel immunized node (SIN).

Population:
Criteria for inclusion include age 18 years or older, expression of HLA-A2, or HLA-A3, and the diagnosis of stage IIB or III abdominal colon cancer. Maximum accrual will be 16 patients.

Inclusion Criteria:

• Patients who have been diagnosed, by histologic examination, with resected abdominal AJCC stage IIB or stage III colon cancer.
• To begin the vaccine regimen, patients must be at least 30 days, but no greater than 60 days post-chemotherapy (5-FU and leucovorin). Patients must be recovered from their surgery and chemotherapy.
• Tumor must express CEA and/or Her-2/neu by immunohistochemistry.
• All patients must have:
  • ECOG performance status 0-1
  • Ability and willingness to give informed consent
• Laboratory parameters as follows:
  • HLA-A2, or -A3 (+)
    ANC > 1000/mm³, and Platelets > 100,000 and Hgb > 9
  • Hepatic:
    • AST and ALT up to 2.5 x upper limits of normal (ULN)
    • Bilirubin up to 2.5 x ULN
    • Alkaline phosphatase up to 2.5 x ULN
  • Renal:
    • Creatinine up to 1.5 x ULN
  • Serology:
    • HIV negative and Hepatitis C negative within 6 months of study entry.
    • LDH up to 1.5 x ULN
• Age 18 years or older at the time of study entry

Lori Elder, Assistant Director
University of Virginia
School of Medicine
Clinical Trials Office
One Morton Drive, Suite 200
Charlottesville VA 22903
Phone: 434-924-8530
Fax: 434-243-5999
EMail: uvaclintrials@virginia.edu

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