Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
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|ClinicalTrials.gov Identifier: NCT00843635|
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : August 13, 2015
Last Update Posted : October 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Tadalafil Other: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pilot Study of Phosphodiesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Arm A - Tadalafil 10mg
Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Other Name: Cialis
Experimental: Arm B - Tadalafil 20mg
Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
Other Name: Cialis
Placebo Comparator: Arm C - Placebo
Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
- Ratio of MDSC Concentration in the Blood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Optimal Dosing Schedule for Tadalafil [ Time Frame: Baseline, End of Treatment at Time of Surgery. ]
- Number of Participants Experiencing Adverse Events [ Time Frame: From Day 1 to Day 20 ]Assessment of Treatment-related Side Effects. Number of participants experiencing adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843635
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Donald T. Weed, MD||University of Miami Sylvester Comprehensive Cancer Center|