Abstract

The objective of this study is to test the efficacy of prolonged low-dose 13-cis Retinoic Acid in reducing risk of second primary tumors in patients who have had head and neck cancer controlled by surgery and/or radiation, and to evaluate the toxicity of low-dose oral 13-cRA administered daily for 3 years. A previous trial established significant activity of 13cRA in preventing second primary tu-mors in squamous cell CA of the head and neck, which occur at a rate of 3 to 4% per year in previously treated patients. GRAMT=M01RR071220077 The objective is to obtain preliminary evidence of the effectiveness of various doses of DMP 504 in the treatment of patients with elevated cholesterol levels. The safety and tolerability of all dosing levels will aslo be assessed. This is a multicenter, randomized, double-blind, placebo-controlled trial of two- panel design that included three DMP 504 dose levels. There will be 6 study sites and sufficient patients enrolled to provide 150 evaluable patients for statistical analysis.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR007122-07
Application #
6282772
Study Section
Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
7
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

Name
Wake Forest University Health Sciences
Department
Type
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106

  Publications

Hong, Jaeyoung; Hatchell, Kathryn E; Bradfield, Jonathan P et al. (2018) Transethnic Evaluation Identifies Low-Frequency Loci Associated With 25-Hydroxyvitamin D Concentrations. J Clin Endocrinol Metab 103:1380-1392
Paek, M-S; Nightingale, C L; Tooze, J A et al. (2018) Contextual and stress process factors associated with head and neck cancer caregivers' physical and psychological well-being. Eur J Cancer Care (Engl) 27:e12833
South, Andrew M; Nixon, Patricia A; Chappell, Mark C et al. (2018) Obesity is Associated with Higher Blood Pressure and Higher Levels of Angiotensin II but Lower Angiotensin-(1-7) in Adolescents Born Preterm. J Pediatr :
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Keaton, Jacob M; Gao, Chuan; Guan, Meijian et al. (2018) Genome-wide interaction with the insulin secretion locus MTNR1B reveals CMIP as a novel type 2 diabetes susceptibility gene in African Americans. Genet Epidemiol 42:559-570
Autmizguine, Julie; Tan, Sylvia; Cohen-Wolkowiez, Michael et al. (2018) Antifungal Susceptibility and Clinical Outcome in Neonatal Candidiasis. Pediatr Infect Dis J 37:923-929
Jilling, Tamas; Ambalavanan, Namasivayam; Cotten, C Michael et al. (2018) Surgical necrotizing enterocolitis in extremely premature neonates is associated with genetic variations in an intergenic region of chromosome 8. Pediatr Res 83:943-953
South, Andrew M; Nixon, Patricia A; Chappell, Mark C et al. (2018) Association between preterm birth and the renin-angiotensin system in adolescence: influence of sex and obesity. J Hypertens 36:2092-2101
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445
Brinkley, Tina E; Leng, Xiaoyan; Nicklas, Barbara J et al. (2017) Racial differences in circulating levels of the soluble receptor for advanced glycation endproducts in middle-aged and older adults. Metabolism 70:98-106

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