Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx

Not Applicable

Completed

Conditions: Head and Neck Cancer

Interventions: Other: Placebo
Drug: Tadalafil

Registration Number: NCT00843635

Lead Sponsor: Donald T. Weed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C - Placebo	Placebo	Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
Arm A - Tadalafil 10mg	Tadalafil	Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Arm B - Tadalafil 20mg	Tadalafil	Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Ratio of MDSC Concentration in the Blood	Baseline, End of Treatment at time of Surgery	Ratio of the number of Myeloid Derived Suppressor Cells (MDSC) in the Blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.
Ratio of T-reg Cell Concentration in the Blood	Baseline, End of Treatment at Time of Surgery	Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery..
Ratio of Tumor-specific T-cell Concentration in the Blood	Baseline, End of Treatment at Time of Surgery	Ratio of the number of tumor specific T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.

Secondary Outcome Measures

Name	Time	Method
Optimal Dosing Schedule for Tadalafil	Baseline, End of Treatment at Time of Surgery.
Number of Participants Experiencing Adverse Events	From Day 1 to Day 20	Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events