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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

Status
Terminated
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00091286
Enrollment
11
Registered
2004-09-09
Start date
2003-03-24
Completion date
2008-02-15
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Craig L Slingluff, Jr
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Safety of the 4-peptide mixture30 days following last vaccineAdverse events
Number of patients with an immune response to the peptidesthrough Day 22T cell responses against the peptides as measured in the sentinel immunized node

Secondary

MeasureTime frameDescription
Immunogenicity of the peptide mixture measured in the peripheral bloodthrough Day 22T cell responses against the peptides and/or tumor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026