Head and Neck Cancer Clinical Trial
Official title:
Pilot Study of Phosphodiesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.
RATIONALE: Biological therapies, such as tadalafil, may stimulate the immune system in
different ways and stop tumor cells from growing.
PURPOSE: This randomized clinical trial is studying how well tadalafil works in treating
patients who are undergoing surgery for cancer of the oral cavity or oropharynx.
OBJECTIVES:
- 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
resection.
- 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
unacceptable toxicity.
- 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
unacceptable toxicity.
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 Fluorescence-activated cell sorting (FACS) and
Immunohistochemistry (IHC).
After completion of study treatment, patients are followed periodically for at least 3
years.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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