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Beta-glucan's Effect on Cetuximab Induced Cytotoxicity in Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Beta-glucan's Effect on Cetuximab Induced Cytotoxicity in Non-Small Cell Lung Cancer


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.


Inclusion Criteria:



- suspected or 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils CR3 and test the cytotoxicity of the primed neutrophils.

Outcome Time Frame:

pre-treatment and post-treatment

Safety Issue:

No

Principal Investigator

Goetz H Kloecker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08.0041

NCT ID:

NCT00682032

Start Date:

April 2008

Completion Date:

March 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
James Graham Brown Cancer Center Louisville, Kentucky  40202