A Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract

NCT00894413 | Completed Phase 2 Results DMC

• 3 other identifiers: J08131R21CA135635-01NA_00012749
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to up to 14 days post-intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo Pill

Tadalafil

EXPERIMENTAL

Tadalafil 20 mg once per day

Drug: Tadalafil

Interventions

Tadalafil DRUG

20 mg once daily for 10 - 14 days

Also known as: Cialis

Tadalafil

Placebo Pill OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 25564570 RESULT

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Zubair Khan, MD
• Organization: Johns Hopkins University School of Medicine

zkhan@jhmi.edu

410-955-3157

Study Officials

• Joseph Califano, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: May 8, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Locations

US (1)