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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.
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
Not yet recruiting
University of Miami
Published on BioPortfolio: 2015-09-10T01:53:23-0400
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.
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
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...
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...
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...
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...
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...
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...
: 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...
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...
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)
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...