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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peptide Vaccine + Montanide + GM-CSF; 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	Biological: HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the 4-peptide mixture	Adverse events	30 days following last vaccine
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of the peptide mixture measured in the peripheral blood	T cell responses against the peptides and/or tumor	through Day 22

Collaborators and Investigators

• Sponsor: Craig L Slingluff, Jr
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Charles M. Friel, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2003
• Primary Completion (Actual): February 15, 2008
• Study Completion (Actual): February 15, 2008

Study Registration Dates

• First Submitted: September 7, 2004
• First Submitted That Met QC Criteria: September 8, 2004
• First Posted (Estimate): September 9, 2004

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: recurrent colon cancer; recurrent rectal cancer; stage IIIB rectal cancer; stage IIIC rectal cancer; stage IIB colon cancer; stage IIIA colon cancer; stage IIB rectal cancer; stage IIIA rectal cancer; stage IIIB colon cancer; stage IIIC colon cancer; stage IVA colon cancer; stage IVB colon cancer; stage IVA rectal cancer; stage IVB rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Monatide (IMS 3015)
• Other Study ID Numbers: 9976; UVACC-GI37; UVACC-23302