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

NCT ID: NCT00091286

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-24
• Study Completion Date: 2008-02-15

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Craig L Slingluff, Jr

OTHER

Sponsor Role: lead

Responsible Party

Craig L Slingluff, Jr

Director, Human Immune Therapy Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles M. Friel, MD

Role: STUDY_CHAIR

University of Virginia

Locations

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

UVACC-GI37

Identifier Type: -

Identifier Source: secondary_id

UVACC-23302

Identifier Type: -

Identifier Source: secondary_id

9976

Identifier Type: -

Identifier Source: org_study_id