Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 5:42 AM
Study NCT ID:
NCT00843635
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tadalafil in Treating Patients Undergoing Surgery for Cancer of the Oral Cavity or Oropharynx
Sponsor:
Donald T. Weed
Organization:
Study Overview
Official Title:
Pilot Study of Phosphodiesterase-5 Inhibitor Tadalafil (Cialis) as an Immunomodulator in Patients With Oral Cavity and Oropharyngeal Squamous Cell Carcinoma.
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SCCC-2008006 | OTHER | UM/Sylvester Comprehensive Cancer Center | View |