Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year
survival estimates of approximately 50%, and is associated with a high rate of systemic
immune impairment as well as evasion of a tumor specific immune response. Preclinical and
clinical data have shown that phosphodiesterase 5 (PDE5) inhibitors (tadalafil) can be used
to augment immune function in HNSCC patients through inhibition of the cancer-induced myeloid
derived suppressor cells (MDSCs).
A multi site phase II, randomized, prospective, biomarker endpoint trial to determine optimum
timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with
conventional therapy for HNSCC.
40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or
placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing
until 90 days after completion of conventional therapy. Tumor-specific T cell responses will
be assessed using HNSCC cell lines, in blood collected before initiation of tadalafil/placebo
and at 60 and 90 days after completion of conventional therapy. Number and function of MDSC
and Treg cells will be assessed before and at 60 and 90 days after completion of conventional
therapy. Prevnar 13® vaccine will be administered 10-14 days after commencing
tadalafil/placebo (before conventional therapy begins) and again at 60 days after completion
of conventional therapy. Vaccine-specific responses assessed at 60 and 90 days
post-conventional therapy will be used to measure the ability of tadalafil to augment immune
response to vaccine.
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