Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer

Early Phase 1

Terminated

• Conditions: Colorectal Cancer
• Interventions: Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine

• Registration Number: NCT00091286
• Lead Sponsor: Craig L Slingluff, Jr

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.

Study Timeline

• Study Start: 2003-03-24
• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-08
• Study First Posted: 2004-09-09
• Primary Completion: 2008-02-15
• Study Completion: 2008-02-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peptide Vaccine + Montanide + GM-CSF	HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunogenicity of the peptide mixture measured in the peripheral blood	through Day 22	T cell responses against the peptides and/or tumor

Trial Locations

Locations (1)

University of Virginia Cancer Center; 🇺🇸 Charlottesville, Virginia, United States