Colon Cancer Clinical Trial
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Charlottesville Virginia, 22908, United States
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