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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00091286
• Other study ID #: 9976
• Secondary ID: UVACC-GI37UVACC-
• Status: Terminated
• Phase: Early Phase 1
• Start date: March 24, 2003
• Est. completion date: February 15, 2008

Study information

• Verified date: March 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 15, 2008
• Est. primary completion date: February 15, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia Cancer Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Craig L Slingluff, Jr	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the 4-peptide mixture	Adverse events	30 days following last vaccine
Primary	Number of patients with an immune response to the peptides	T cell responses against the peptides as measured in the sentinel immunized node	through Day 22
Secondary	Immunogenicity of the peptide mixture measured in the peripheral blood	T cell responses against the peptides and/or tumor	through Day 22