Phase 1/2 Study of Tadalafil + Vaccine in HNSCC

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Researchers are evaluating whether tadalafil improves the response to vaccination among patients with recurrent head and neck squamous cell carcinoma.
Researchers are evaluating whether tadalafil improves the response to vaccination among patients with recurrent head and neck squamous cell carcinoma.

Title: PDE5 Inhibition Via Tadalafil (Cialis®) to Enhance Anti-Tumor MUC1 Vaccine Efficacy in Patients With Resectable, and Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase I/II Clinical Trial1

Principal Investigators: Donald T. Weed, MD, FACS, University of Miami

Description: For this randomized, phase 1/2 study, researchers are evaluating whether tadalafil improves the response to vaccination among patients with recurrent head and neck squamous cell carcinoma. Patients in whom a second primary tumor is detected are also eligible.

Tadalafil lowers myeloid derived suppressor cells and regulatory T cells, which may improve the immunoresponse among vaccine-treated patients with minimal residual disease.

Patients will be randomized to 1 of 3 groups: in the first, patients will receive tadalafil, an anti-MUC1 vaccine, and an anti-influenza vaccine, in the second, patients will receive tadalafil and a placebo vaccine, and in the third patient will receive tadalafil placebo and both an anti-MUC1 vaccine and an anti-influenza vaccine.

There will also be a non-randomized group in which eligible patients are unwilling to receive the experimental treatment. These patients will undergo standard resection and will be followed for recurrence.

The primary phase 1 outcomes include toxicity; the primary phase 2 outcomes include tumor-specific immune response. Secondary outcomes include recurrence-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02544880.

Status: This study is open and recruiting patients as of April 11, 2017.

Reference

  1. Clinicaltrials.gov. PDE5 inhibition via tadalafil to enhance anti-tumor mucin 1 (MUC1) vaccine efficacy in patients with HNSCC. NCT02544880. https://clinicaltrials.gov/ct2/show/NCT02544880. Accessed April 11, 2017.

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