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.

Condition	Treatment or Intervention
Colon Cancer Rectal Cancer	Drug: HER-2-neu peptide vaccine  Drug: Montanide ISA-51  Drug: carcinoembryonic antigen peptide vaccine  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-specific immune-modulator therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy

Further Study Details: 

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 16 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

PRIOR CONCURRENT THERAPY: Biologic therapy

• More than 4 weeks since prior immunotherapy
• More than 4 weeks since prior growth factors
• More than 4 weeks since prior allergy shots
• No prior vaccination with any study peptides for malignancy

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• At least 30 days, but ≤ 6 months, since prior therapy for colorectal cancer

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study chairs or principal investigators

Craig L. Slingluff, MD,  Study Chair,  University of Virginia, Health Sciences Center Cancer Center   

Study ID Numbers:  CDR0000386177; UVACC-GI37; UVACC-23302; UVACC-HIC-9976; NCT00091286
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00091286
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08