Non Small Cell Lung Cancer (NSCLC) Clinical Trial
— NitroglycerinOfficial title:
Nitroglycerin as a Sensitizer in the Treatment of Non Small Cell Lung Cancer: a Phase II Trial
Verified date | February 2019 |
Source | Maastricht Radiation Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nitroglycerin is a nitric oxide donor which is mainly known as a vasodilating agent used in
ischemic heart disease. It has also been shown to increase tumor blood flow in animal and
human tumors.
The addition of nitroglycerin to chemotherapy in non small cell lung cancer has been shown to
generate very favorable response rates with respect to standard treatment schedules[5].
Theoretically nitroglycerin might reduce resistance to chemotherapy via a plethora of
different effects: better tumor perfusion, direct effects of NO on cancer cells, increase in
activated p53 protein and via an increased blood flow in the tumour with as consequence a
higher drug concentration in the tumor [6] .
In mice, nitric oxide donors such as isosorbide dinitrate have been shown to decrease tumor
hypoxia by better tumor perfusion, which could enhance radiotherapy responses [7].
To date these combined effects have not been tested in humans. In this trial we would like to
demonstrate the effect of nitroglycerin on tumor perfusion and hypoxia in non small cell lung
cancer (using DCE and HX4 scanning), providing a rationale for further study and to test the
effect of combining nitroglycerine to standard treatment of NSCLC
(radiotherapy/chemotherapy).
Status | Terminated |
Enrollment | 47 |
Est. completion date | March 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Non-small cell lung cancer stage IB-IV amenable for radiotherapy with curative intent. - (Stage IV patients with oligometastic (1-4 metastases) NSCLC are regularly treated radically in the IKNL region). - Patients not included in the PET-Boost or the Lucanix trial. - WHO performance status 0-2. - Willing and able to comply with the study prescriptions. - 18 years or older. - Ability to give and having given written informed consent before patient registration. - No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction). - No radiotherapy in 4 weeks prior to this study. - No treatment with investigational drugs in 4 weeks prior to or during this study. - No known allergy to nitroglycerin or nitroglycerin patch. - No known allergy to iodine based contrast agents - No use of Levitra, Viagra or Cialis at the time of application of the nitroglycerin patch. - No conditions necessitating the use of ergot alkaloids, alpha blockers (eg tamsulosine), betablockers or calcium channel blockers on the day of nitroglycerin patch application). - No other active malignancy. - No major surgery (excluding diagnostic procedures like eg mediastinoscopy) in previous 4 weeks. - Adequate renal function: calculated creatinine clearance at least 60ml/min. |
Country | Name | City | State |
---|---|---|---|
Netherlands | MAASTRO clinic | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology | Anticancer Fund, Belgium, Reliable Cancer Therapies |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase of 2 year overall survival of 15% vs historical controls | 2 years | ||
Secondary | Demonstrate effect on enhancement on tumor perfusion | 3 days | ||
Secondary | Toxicity | 7 weeks | ||
Secondary | Demonstrate the effect on enhancement of tumor oxygenation | 3 days | ||
Secondary | Evaluating the possible value of Perfusion CT and hypoxia scans on treatment with nitroglycerin of NSCLC | 2 years |
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