Pilot Study of Phosphodioesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.
- To analyze the phenotype and the function of the tumor-induced suppressive network
associated with squamous cell carcinoma (SCC) of the head and neck in patients with SCC
of the oral cavity or oropharynx treated with tadalafil followed by definitive surgical
- To analyze the immune response before and after treatment with tadalafil to determine
whether or not tadalafil treatment modulates in these patients.
- To compare two doses of tadalafil to determine whether there are measurable differences
in immune response in these patients.
- To analyze treatment-related side effects of tadalafil at each of the two doses tested
in these patients.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral tadalafil once daily on days 1-20 in the absence of
- Arm II: Patients receive oral tadalafil (at a higher dose than in arm I) once daily on
days 1-20 in the absence of unacceptable toxicity.
- Arm III: Patients receive oral placebo once daily on days 1-20 in the absence of
All patients undergo scheduled definitive surgical resection on day 23.
Patients undergo blood sample collection at baseline, on day 20, and at 6 weeks after
surgical resection for correlative laboratory studies. Patients also undergo tumor tissue
sample collection at baseline and at the time of surgical resection. Samples are analyzed
for immunological markers by FACS and IHC.
After completion of study treatment, patients are followed periodically for at least 3
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Immune response as assessed by number of CD4+ and CD8+ cells in tumor tissue by IHC and proliferation of CD8+ lymphocytes in peripheral blood mononuclear cells by FACS
The primary endpoint, patient immune response, will be assessed by several parameters quantifying the presence and function of MDSC and T cell populations at the time of surgery as compared to pre-treatment.
Donald T. Weed, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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