Head and Neck Squamous Cell CarcinomaPhase 2NCT00894413
A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
A Phase 2 study testing Tadalafil in people with Head and Neck Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Tadalafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2007to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Tadalafil, Placebo Pill
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called Cialis
20 mg once daily for 10 - 14 days
Placebo PillOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Pill |
| Tadalafil | Experimental | Tadalafil 20 mg once per day Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immune Response After Tadalafil Administration
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.
Measured: Change from baseline to up to 14 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study start8 May 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Califano, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894413
- Sponsor's protocol ID
- J0813
- Other IDs
- 1R21CA135635-01, NA_00012749
- Status last verified
- May 2019
- First submitted
- 5 May 2009
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Califano JA, Khan Z, Noonan KA, Rudraraju L, Zhang Z, Wang H, Goodman S, Gourin CG, Ha PK, Fakhry C, Saunders J, Levine M, Tang M, Neuner G, Richmon JD, Blanco R, Agrawal N, Koch WM, Marur S, Weed DT, Serafini P, Borrello I. Tadalafil augments tumor specific immunity in patients with head and neck squamous cell carcinoma. Clin Cancer Res. 2015 Jan 1;21(1):30-8. doi: 10.1158/1078-0432.CCR-14-1716.
PubMed 25564570
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
- ClinicalTrials.gov ID
- NCT00894413
- Acronym / sponsor ID
- J0813
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2007 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo Pill |
| Tadalafil | Experimental | Drug: TadalafilTadalafil 20 mg once per day |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TadalafilAlso: Cialis20 mg once daily for 10 - 14 days | Drug | Tadalafil |
| Placebo PillPlacebo | Other | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25564570Califano JA, Khan Z, Noonan KA, Rudraraju L, Zhang Z, Wang H, Goodman S, Gourin CG, Ha PK, Fakhry C, Saunders J, Levine M, Tang M, Neuner G, Richmon JD, Blanco R, Agrawal N, Koch WM, Marur S, Weed DT, Serafini P, Borrello I. Tadalafil augments tumor specific immunity in patients with head and neck squamous cell carcinoma. Clin Cancer Res. 2015 Jan 1;21(1):30-8. doi: 10.1158/1078-0432.CCR-14-1716.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Califano, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tadalafil in people with Head and Neck Squamous Cell Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Immune Response After Tadalafil Administration (time frame: Change from baseline to up to 14 days post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00894413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.