Expired Study
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Charlottesville, Virginia 22908


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

CDR0000386177


NCT ID:

NCT00091286


Secondary ID:

UVACC-GI37


Study Acronym:


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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Charles M. Friel, MD
Study Chair
University of Virginia

Study Dates

Start Date:March 2003
Primary Completion Date:April 2011
Primary Completion Type:Anticipated
Verification Date:October 2007
Last Changed Date:November 13, 2010
First Received Date:September 7, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety of the 4-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity at day 22
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Immunogenicity of the peptide mixture by Elispot assay at day 22
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:HER-2-neu, CEA peptides, GM-CSF, Montanide ISA-51

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Virginia
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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