Suspended

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

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What is being tested

HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine

Biological
Who is being recruted

Colonic Diseases+8

+ Digestive System Diseases

+ Digestive System Neoplasms

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: March 2003
See protocol details

Summary

Principal SponsorCraig L Slingluff, Jr
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 24, 2003

Actual date on which the first participant was enrolled.

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 TitleEvaluation 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 
NCT00091286
Principal SponsorCraig L Slingluff, Jr
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesColorectal Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Virginia Cancer Center

Charlottesville, United StatesSee the location
SuspendedOne Study Center