This trial is active, not recruiting.

Condition colorectal cancer
Treatment her-2-neu, cea peptides, gm-csf, montanide isa-51 vaccine
Sponsor University of Virginia
Collaborator National Cancer Institute (NCI)
Start date March 2003
End date April 2011
Trial size 15 participants
Trial identifier NCT00091286, CDR0000386177, UVACC-23302, UVACC-GI37, UVACC-HIC-9976


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22
time frame:
Immunogenicity of the peptide mixture by Elispot assay at day 22
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).