PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC

2015-09-10 01:53:23 | BioPortfolio


The investigators hypothesize that Tadalafil treatment, by lowering Myeloid Derived Suppressor Cells (MDSCs) and regulatory T cells (Tregs), can prime an antitumor immune response and promote a permissive environment that should increase the efficacy of anti-tumor vaccine in a setting of minimal residual disease.


The investigators will perform a phase I/II placebo-controlled clinical trial in patients with HNSCC whose tumor has recurred, or secondary primary tumor is detected, post conventional radiotherapy with or without prior surgery or chemotherapy. For these patients, salvage surgery is the only standard curative therapeutic option, post-surgical recurrence rate is high, and life expectancy is poor. Patients will be given Tadalafil (or Placebo) in combination with vaccination (anti-MUC1 + anti-Influenza vaccines or placebos) prior to surgery, and in 3 additional courses after surgery in combination with anti-MUC1/anti-Influenza vaccines (or placebo vaccines). A final booster vaccination (with anti-MUC1/anti-Influenza vaccines or placebo vaccines alone) will be administered approximately one-year post salvage surgery. Response to treatment will include antigen-specific immune response and characterization of the leukocytes subset. As a secondary endpoint, tumor recurrence at 2 years will be evaluated to determine whether a trend toward a beneficial prognosis might be observed in treated patients.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Head and Neck Squamous Cell Carcinoma


Tadalafil, Anti-MUC1 Vaccine, Anti-Influenza Vaccine, Tadalafil Placebo, Vaccine Placebo, Peripheral Blood Collection, DTH Skin Test, Tumor-specimen collection


University of Miami
United States


Not yet recruiting


University of Miami

Results (where available)

View Results


Published on BioPortfolio: 2015-09-10T01:53:23-0400

Clinical Trials [7803 Associated Clinical Trials listed on BioPortfolio]

To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.

PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

A Study of Tadalafil for Duchenne Muscular Dystrophy

The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safe...

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

Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year survival estimates of approximately 50%, and is associated with a high rate of systemic immune impair...

Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

This is a randomized, double-blind, placebo-controlled, parallel-design, multinational, 12-week study to compare the efficacy, dose response, and safety of tadalafil once a day versus plac...

PubMed Articles [9376 Associated PubMed Articles listed on BioPortfolio]

Effects of masitinib compared with tadalafil for the treatment of monocrotaline-induced pulmonary arterial hypertension in rats.

Targeting vascular remodeling in pulmonary arterial hypertension (PAH) remains a challenge given the lack of potent anti-remodeling abilities of the therapeutic drugs. Although sildenafil has been sho...

Vaccine effectiveness of cell-culture relative to egg-based inactivated influenza vaccine during the 2017-18 influenza season.

There is concern that influenza vaccine effectiveness (VE) may be attenuated by passage in eggs during manufacture. We compared quadrivalent cell-culture vaccine with egg-based vaccines, most of which...

Influenza Vaccine Efficacy and Effectiveness in Pregnant Women: Systematic Review and Meta-analysis.

Pregnant women have a high risk for complications from influenza infection, but vaccination rates within this group remain low in the US and other countries. The efficacy and effectiveness of the infl...

Seasonal influenza vaccination among older adults in Jordan: prevalence, knowledge, and attitudes.

: The current study aimed to evaluate the prevalence, level of knowledge and attitudes to seasonal influenza vaccination among older adults in Jordan.: This was a cross-sectional study in which a clos...

Patterns of influenza B circulation in Latin America and the Caribbean, 2010-2017.

There are limited published data about the circulation of influenza B/Victoria and B/Yamagata in Latin America and the Caribbean (LAC) and most countries have a vaccine policy that includes the use of...

Medical and Biotech [MESH] Definitions

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

More From BioPortfolio on "PDE5 Inhibition Via Tadalafil to Enhance Anti-Tumor Mucin 1 (MUC1) Vaccine Efficacy in Patients With HNSCC"

Quick Search

Relevant Topic

Erectile Dysfunction
Erectile dysfunction (ED or impotence) is the inability to get and maintain an erection that is sufficient for satisfactory sexual intercourse, and affects half of all men between the ages of 40 to 70. The causes of ED can be both physical and psycholo...

Searches Linking to this Trial