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.
Verified date | September 2015 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
INCLUSION CRITERIA: - Patients with surgically resectable oral cavity SCC, all subsites, T1 - T4, N0 - N3 - Patients with surgically resectable oropharyngeal SCC, all subsites, T1 - T2, N0 - N1 - Patients with surgically resectable T4 oropharyngeal SCC, all subsites, N0 - N3 - Patients must be 18 years old or older EXCLUSION CRITERIA: - Patients with previous surgical resection, radiation, or chemotherapy will be excluded to rule out possible effects of local tissue changes secondary to previous treatment - Patients with surgically unresectable disease at primary site or regional lymph nodes - Patients with T1 - T2 SCC oropharynx, N2 - N3 - Patients with T3 SCC oropharynx , N0 - N3 - Any patient for whom non-surgical therapy is recommended as treatment of choice after multidisciplinary treatment evaluation - Patients with an altered mental status or not capacitated for their medical decision making - Patients with severe or unstable cardiac or cerebrovascular disease are excluded - myocardial infarction within the last 90 days - unstable angina or angina occurring during sexual intercourse - New York Heart Association Class 2 or greater heart failure in the last 6 months - uncontrolled arrhythmias - hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg) - stroke within the last 6 months - Left ventricle outflow obstruction. - Pregnant and nursing mothers will not be enrolled given unknown effects to offspring - Concurrent nitrate, alpha-blocker, or cytochrome P-450 inhibitor use - Renal Insufficiency defined as creatinine clearance less than 51. - Creatinine clearance will be determined by the following Cockcroft-Gault Equation: (140-age) * (Wt in kg) * (0.85 if female) / (72 * Cr) - Patients with hepatic insufficiency. - Patients currently taking a Phosphodiesterase (PDE) inhibitors for erectile dysfunction - Patients who are immunocompromised, for reasons not directly related to patients malignancy - Patients with significant alcohol or drug abuse - Patients with unilateral blindness, hereditary retinal disorders, or increased risk of blindness - Patients with unilateral deafness, history of hearing loss, hearing aid dependence, or clinically evident hearing loss |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Donald T. Weed |
United States,
Weed DT, Vella JL, Reis IM, De la Fuente AC, Gomez C, Sargi Z, Nazarian R, Califano J, Borrello I, Serafini P. Tadalafil reduces myeloid-derived suppressor cells and regulatory T cells and promotes tumor immunity in patients with head and neck squamous ce — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of MDSC Concentration in the Blood | 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. | Baseline, End of Treatment at time of Surgery | No |
Primary | Ratio of T-reg Cell Concentration in the Blood | Ratio of the number of regulatory T cells in the blood, per treatment group, from Baseline to End of Treatment at Time of Surgery.. | Baseline, End of Treatment at Time of Surgery | No |
Primary | Ratio of Tumor-specific T-cell Concentration in the Blood | 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. | Baseline, End of Treatment at Time of Surgery | No |
Secondary | Optimal Dosing Schedule for Tadalafil | Baseline, End of Treatment at Time of Surgery. | No | |
Secondary | Number of Participants Experiencing Adverse Events | Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events | From Day 1 to Day 20 | Yes |
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