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

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
Sponsored by
Craig L Slingluff, Jr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage IIB rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peptide Vaccine + Montanide + GM-CSF

Arm Description

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

Outcomes

Primary Outcome Measures

Safety of the 4-peptide mixture
Adverse events
Number of patients with an immune response to the peptides
T cell responses against the peptides as measured in the sentinel immunized node

Secondary Outcome Measures

Immunogenicity of the peptide mixture measured in the peripheral blood
T cell responses against the peptides and/or tumor

Full Information

First Posted
September 7, 2004
Last Updated
March 26, 2020
Sponsor
Craig L Slingluff, Jr
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00091286
Brief Title
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Slow accruals
Study Start Date
March 24, 2003 (Actual)
Primary Completion Date
February 15, 2008 (Actual)
Study Completion Date
February 15, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Craig L Slingluff, Jr
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IIB colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage IIB rectal cancer, stage IIIA rectal cancer, stage IIIB rectal cancer, stage IIIC rectal cancer, stage IVA rectal cancer, stage IVB rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peptide Vaccine + Montanide + GM-CSF
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51 vaccine
Primary Outcome Measure Information:
Title
Safety of the 4-peptide mixture
Description
Adverse events
Time Frame
30 days following last vaccine
Title
Number of patients with an immune response to the peptides
Description
T cell responses against the peptides as measured in the sentinel immunized node
Time Frame
through Day 22
Secondary Outcome Measure Information:
Title
Immunogenicity of the peptide mixture measured in the peripheral blood
Description
T cell responses against the peptides and/or tumor
Time Frame
through Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles M. Friel, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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