Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Influenza, Human

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

All Drugs and Chemicals

Vasodilator Agents

Urological Agents

Herbal and Botanical

Vaccines

Tadalafil

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Cola

Cialis 20 mg daily by mouth for 16 day. 5 days prior to surgery, day of surgery and 10 days post surgery.

Influenza vaccine 0.5mL day of surgery

No intervention in the perioperative period

Cialis

One 0.5mL intramuscular injection the day of surgery

Influenza vaccine

Rebecca Auer, Doctor

The purpose of this study is to determine if giving Cialis for 5 days prior to surgery, on the day of surgery along with the influenza vaccine and Cialis 10 days after surgery will have an affect at the cell level for decreasing the chances of the spread of disease post surgery.

Surgical resection of a primary malignancy, while critical for cure, results in postoperative immune suppression, characterized by MDSC mediated inhibition of NK cell killing. In preclinical models the causal link between this immune suppression and the formation of postoperative metastases is undeniable. Fortunately, this postoperative immune suppression is preventable using modulators of MDSC and NK cell function. In this Phase Ib study the hypothesis is that simultaneous administration of perioperative tadalafil, to prevent MDSCs from suppressing NK cells, and influenza vaccine, to directly activate NK cells will safely and effectively reverse the effects of surgical stress on NK cell cytotoxicity. This is a necessary first step towards demonstrating that this re-purposed perioperative regimen can reduce the formation of postoperative metastatic disease in cancer surgery patients.

In this proposed Phase I trial a carefully selected promising perioperative immunomodulatory regimen, which includes tadalafil and influenza vaccination, for rapid clinical translation. The proposal is to re-purpose these drugs, they already have ample safety data associated with their use but neither agent has been systematically administered immediately prior to surgery. This trial will allow us to not only establish the safety of this regimen but will permit a rigorous assessment of its ability to reverse surgery-induced suppression of NK cells. If this regimen can effectively prevent postoperative NK cell dysfunction without any regimen limiting toxicity then this will provide the necessary data required to undertake a randomized efficacy study in a specific cancer subtype, with cancer recurrence as the primary endpoint.

Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy

PERIOP-04 Phase Ib Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy

Adverse events, vitals and medications will be collected.

Ottawa Hospital Research Institute

Neoplasms

Digestive System Diseases

Mouth and Tooth Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Mouth Diseases

Stomatognathic Diseases

Esophageal Cancer

Oral Cancer

Antineoplastic Agents

Nivolumab

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tadalafil for up to 12 months and pembrolizumab for up to 24 months.

Khushbu Singh

Joseph Califano

This study will examine the combination of pembrolizumab and tadalafil for safety and efficacy in advanced head and neck cancer.

Immune competent animal models of HNSCC demonstrate that combination PDE-5 inhibitor (tadalafil) and PD-1 inhibitor therapy is more effective than either therapy alone based on the concept of targeting multiple immune repressive abnormalities simultaneously (PD-1 checkpoint and myeloid suppressive pathways).

This trial will test the hypothesis that combination PD-1 inhibition and PDE-5 inhibition can be safely co-administered, and secondarily test the hypothesis that the combination of both therapies will be more effective than PD-1 inhibition alone in recurrent/metastatic HNSCC.

Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer

A Phase II Study of Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Rate of dose limiting toxicity at least possibly attributable to study treatment

Overall survival at 12 months post-enrollment

University of California, San Diego

Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy	NCT02998736	Abdominal Cance...	Cialis Influenza vacci...	18 Years -	Ottawa Hospital Research Institute
Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer	NCT03993353	Head and Neck C... Head and Neck S... Head and Neck C... Head and Neck C... Head and Neck C... Head and Neck C... Cancer Cancer of Esoph... Cancer, Metasta... Cancer of Head ... Cancer of Mouth Cancer of Neck	Pembrolizumab Tadalafil	18 Years -	University of California, San Diego
Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy	NCT02998736	Abdominal Cance...	Cialis Influenza vacci...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for cialis

Every month we try and update this database with for cialis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cialis

Every month we try and update this database with for cialis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cialis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.