None listed
Conditions
Brief summary
This study aims to evaluate the efficacy of treating glioblastoma patients with oral medications that target the renin-angiotensin system, and are commonly used for treating other conditions. Who is it for? You may be eligible for this study if you are aged 16 to 80 years and have histologically confirmed glioblastoma for which you have completed surgery (biopsy or debulking) and chemoradiotherapy involving Temozolomide, or radiotherapy alone. Study details Participants will be given gradually increasing doses of oral medications including Aliskiren, Celecoxib, Curcumin, Metformin, Propranolol and Quinapril for up to 4 years. Data will be collected on overall survival, progression of glioblastoma tumour, quality of life and performance status. It is hoped that data from this study will determine the efficacy of treatment targeting the renin-angiotensin system in glioblastoma patients.
Interventions
All trial drugs are administered orally, and will be introduced in a step-wise fashion, with each drug titrated until the optimal dose as per the protocol.
The study treatment consists of six oral medications. The dosage of the medications is increased over a 4 week period, and the treatment is maintained for the duration of the study. The total duration of the study is approximately 4 years.
The dosing regime is as follows;
1) Aliskiren - week 0 - 150mg once daily, continue at this dose fo
All trial drugs are administered orally, and will be introduced in a step-wise fashion, with each drug titrated until the optimal dose as per the protocol. The study treatment consists of six oral medications. The dosage of the medications is increased over a 4 week period, and the treatment is maintained for the duration of the study. The total duration of the study is approximately 4 years. The dosing regime is as follows; 1) Aliskiren - week 0 - 150mg once daily, continue at this dose for the remainder of the study 2) Curcumin with piperine - week 0 - 150mg once daily, continue at this dose for the remainder of the study 3) Celecoxbi - week 0 - 200mg once daily, continue at this dose for the remainder of the study 4) Metformin - week 0 - 250mg once daily ; increased every week to achieve optimal dose of 500mg twice daily, continue at this dose for the remainder of the study 5) Quinapril - to be introduced on week 1 at 5mg once daily; increased every week to achieve optimal dose of 20mg once daily, continue at this dose for the remainder of the study 6) Propranolol - to be introduced on week 4; increased every week to achieve optimal dose of 40mg in the morning and 80mg in the evening, continued for the remainder of the study Renal function, complete blood count, blood pressure and pulse rate are monitored.
Sponsors
Gillies McIndoe Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with histologically confirmed glioblastoma who have completed surgery (biopsy or debulking) and chemoradiotherapy or who have had radiotherapy alone, and have a good performance status with a Karnofsky score of at least 60. Note the chemotherapy treatment is temozolomide (TMZ).
Exclusion criteria
1. Are unable to provide informed consent 2. Are unable to swallow tablets and capsules 3. Have persistent platelet count of less than 100/µL 4. Have not completed surgery and first cycle of TMZ concomitant with radiotherapy 5. Require on-going treatment with medications that increase renin levels, such as calcium channel blockers and diuretics 6. Are not motivated including those who are non-adherent, e.g., abuse alcohol 7. Less than 16 years 8. Older than 80 years 9. On other studies or trials 10. Have contraindications to any of the study treatments including asthma, systolic blood pressure (BP) less than or equal to 100mmHg and pulse rate of less than 60 per minute (except in young and fit patients who normally have BP less than or equal to 100mmHg and pulse rate of less than 60 per minute and have an ECG that excludes arrhythmia), allergies to the trial medications, medications that interfere with the proposed treatments 11. Have significant immune compromise including HIV infection, organ transplant patients on immunosuppression, chronic lymphocytic leukaemia 12. Breastfeeding, pregnant or plan to be pregnant 13. Have terminal organ failure: a. Moderate or severe renal impairment (GFR less than 60mL/min) b. Liver disease c. Congestive heart failure/myocardial infarction within the last 6 months. d. Cerebrovascular disease (CVA/TIA/hemiplegia, except mild dementia). e. Moderate or severe peripheral vascular disease. 14. Have a second cancer that is expected to impact on the results of this study.
Outcome results
None listed