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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of colorectal cancer Stage IIB, III, or IV disease HLA-A2- or -A3-positive PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Hemoglobin > 9 g/dL Platelet count > 100,000/mm^3 Hepatic Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Other 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 PRIOR CONCURRENT THERAPY: 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 Chemotherapy More than 30 days since prior chemotherapy Endocrine therapy More than 30 days since prior steroids Radiotherapy More than 30 days since prior radiotherapy Surgery More than 30 days since prior surgery Other At least 30 days, but ≤ 24 months, since prior therapy for colorectal cancer No concurrent illegal drug use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peptide Vaccine + Montanide + GM-CSF<br>Colon peptide mixture (100 mcg each of the 4 peptides) plus 190 mcg of tetanus toxoid peptide, plus GM-CSF (110 mcg) in Montanide ISA-51 adjuvant | Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the 4-peptide mixture | Adverse events | 30 days following last vaccine | 
| Number of patients with an immune response to the peptides | T cell responses against the peptides as measured in the sentinel immunized node | through Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity of the peptide mixture measured in the peripheral blood | T cell responses against the peptides and/or tumor | through Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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