Colorectal Cancer
Conditions
Keywords
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
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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the 4-peptide mixture | 30 days following last vaccine | Adverse events |
| Number of patients with an immune response to the peptides | through Day 22 | T cell responses against the peptides as measured in the sentinel immunized node |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of the peptide mixture measured in the peripheral blood | through Day 22 | T cell responses against the peptides and/or tumor |
Countries
United States