- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00894413
A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
May 22, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
The purpose of this trial is to determine whether or not Cialis (tadalafil) administered to head and neck squamous cell cancer patients augments immune response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma OR histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence).
- Disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
- No medical contraindication to biopsy of target lesion.
- ECOG performance status 0-1
Required laboratory data (to be obtained within 4 weeks of initiation):
- Platelets > 75,000/mm³
- Calculated Creatinine Clearance (CRCL)> 60 mL/min iii. Total serum bilirubin < 1.5 mg/dL.
- No intercurrent illness likely to prevent protocol therapy or surgical resection
- Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds five years.
- Female patients must not be pregnant or breast feeding. A negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
- Willingness and ability to give signed written informed consent.
Exclusion Criteria:
- Known severe hypersensitivity to tadalafil or any of the excipients of this product
- Patients who have a concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer) who have a survival prognosis of < 5 years.
- Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
- Incomplete healing from previous oncologic or other major surgery.
- Pregnancy or breast feeding (women of childbearing potential).
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
- Current therapy with ketoconazole or oral antifungal therapy.
- History of significant hypotensive episode requiring hospitalization.
- A history of acute myocardial infarction within prior 3 months, uncontrolled angina,
- Uncontrolled arrhythmia, or uncontrolled congestive heart failure
- Age < 18
History of any of the following cardiac conditions:
- Angina requiring treatment with long-acting nitrates.
- Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration.
- Unstable angina within 90 days of visit 1 (Braunwald 1989).
- Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
History of any of the following coronary conditions within 90 days of planned tadalafil administration:
- Myocardial Infarction.
- Coronary artery bypass graft surgery.
- Percutaneous coronary intervention (for example, angioplasty or stent placement).
- Any evidence of heart disease (NYHA≥Class III as defined in Protocol Attachment LVHG.3) within 6 months of planned tadalafil administration
- Current treatment with nitrates.
- Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitor such as ketoconazole or ritonavir.
- Received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of Visit 1.
- Prior chronic immune suppressive state (AIDS, immunosuppressive therapy).
- History of hypotension and/or blindness during prior treatment with Tadalafil or other PDE-5 inhibitors.
- prior history of non-arterial ischemic optic retinopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo
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Experimental: Tadalafil
Tadalafil 20 mg once per day
|
20 mg once daily for 10 - 14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Immune Response After Tadalafil Administration
Time Frame: Change from baseline to up to 14 days post-intervention
|
Median fold-change in immune response of T-cell expansion, delayed-type hypersensitivity reactions, CD4/CD69, CD8/CD69.
A positive value indicates an increase in immune response.
|
Change from baseline to up to 14 days post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph Califano, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2007
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
May 5, 2009
First Submitted That Met QC Criteria
May 6, 2009
First Posted (Estimate)
May 7, 2009
Study Record Updates
Last Update Posted (Actual)
June 11, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Tadalafil
Other Study ID Numbers
- J0813
- 1R21CA135635-01 (U.S. NIH Grant/Contract)
- NA_00012749 (Other Identifier: JHM IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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