Official Title: “Beta-Glucan's Effect on Cetuximab Induced Cytotoxicity in Non-Small Cell Lung Cancer”

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Study Type: Interventional

Study Design: Basic Science, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Beta-glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. Imucell WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.

Intervention(s) in this Clinical Trial

• Dietary Supplement: beta-glucan
  • 1 250mg beta-glucan capsule, 3 times a day, for 21 days

Primary Measures

• blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils CR3 and test the cytotoxicity of the primed neutrophils.
  • Time Frame: pre-treatment and post-treatment
    Safety Issue?: No

Inclusion Criteria:

• definitive diagnosis of non-small cell lung cancer (NSCLC)
• must be treatment naive
• ability to swallow pills
• ECOG performance status of 0 to 3
• absolute neutrophil count (ANC) greater than or equal to 1500/microl
• ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• history of hypersensitivity reactions attributed to beta-glucan
• currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
• presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: James Graham Brown Cancer Center

Overall Clinical Trial Officials and Contacts

Goetz H Kloecker, MD Principal Investigator James Graham Brown Cancer Center  

Overall Contact: Jamie M Day, BSN (502) 562-3429 jmluka01@louisville.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682032

Study ID Number: 08.0041

ClinicalTrials.gov Identifier: NCT00682032

Health Authority: United States: Institutional Review Board

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