A Phase II Trial of Preoperative Soy Isoflavone Supplementation and Molecular Markers in the Prevention of Head and Neck Squamous Carcinoma

Status
Active
Cancer Type
Thyroid Cancer
Trial Phase
Phase II
Eligibility
19 to 80, Male and Female
Study Type
Treatment
NCD ID
NCT01028001
Protocol IDs
UMCC 2009.008 (primary)
HUM%26957
Study Sponsor
University of Michigan Comprehensive Cancer Center

Summary

We hypothesize that p16 hypermethylation in tumor and adjacent non-tumor mucosa identifies patients who have impaired response to stress signals associated with smoking, and that p16 hypermethylation and associated over expression of downstream targets such as COX-2, VEGF, EGFR and IL6 can be abrogated by soy isoflavone supplementation.

Objectives

The overall long term goal of the proposed research is to determine if administration of a soy isoflavone will provide a basis for secondary prevention and cancer control that can decrease tumor recurrence and increase overall survival and quality of life in patients with head and neck squamous carcinoma. Secondarily, we hope to identify candidate genes and intermediate endpoints for future primary prevention trials. The inclusion of Karmanos Cancer Institute and Emory University will provide additional new patient accrual and improved access to minority patients.

We will conduct a Phase II trial to determine whether short term (3 weeks) soy isoflavone administration can modulate p16 methylation and tissue expression of p53, p16, EGFR, VEGF, Bcl-xL and COX-2 in resected specimens and adjacent non-tumor mucosa to potentially identify markers useful as intermediate endpoints and define how quickly changes in gene markers might be seen. Correlation of pretreatment tissue markers with serum and saliva markers will be determined to identify potential surrogates of tissue markers that could be useful in serial monitoring protocols in patients or high risk populations with oral leukoplakia or dysplasia where serial tumor specimens are not available. This protocol is designed to provide a comprehensive assessment of adjuvant soy isoflavone and molecular markers in a prospective clinical trial setting. Accrual will be enhanced by the addition of Karmanos Cancer Institute and Emory University.

Treatment Sites in Georgia


Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Study Coordinator:
Stephanie McMillan
404-686-1855

Doctors:

Nabil F. Saba MD, FACP

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Rachel Moreno-Williams
404-778-4147

Doctors:

Amy Y. Chen MD
William J. Grist MD
Nabil F. Saba MD, FACP
Dong Moon Shin MD