A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)
- Registration Number
- NCT01602588
- Lead Sponsor
- University College, London
- Brief Summary
There is emerging evidence that hydroxychloroquine (HCQ), a drug used commonly in the prevention/ treatment of malaria, rheumatoid arthritis and lupus erythematosus, may improve survival outcome in a variety of cancers including HGG, with few side effects.
In this trial the investigators wish to investigate whether treatment with radiotherapy and hydroxychloroquine is more effective than treatment with radiotherapy alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Male and female patients aged ≥70 yrs identified through the neurooncology MDT.
- A histological diagnosis of HGG, either from biopsy or resection.
- A life expectancy of > 2 months
- An ECOG performance status of 0/1
- Absolute neutrophil count ≥ 1.5 x 109
- Platelet count ≥ 100 x 109
- Bilirubin ≤ 1.5 mg/dL (or ≤ 25.6 µmol/L)
- Creatinine ≤ 2 times upper limit of normal (ULN)
- ALT and AST ≤ 4 times ULN
- Mini Mental Status Exam score ≥ 17 (Appendix 10)
- Written informed consent
- Ready to start radiotherapy within 4 weeks of surgery
- Concurrent psoriasis unless the disease is well controlled and patient is under the care of a specialist for the disorder who agrees to monitor for exacerbations
- Prior macular degeneration or diabetic retinopathy
- Concurrent serious infection or medical illness that would preclude study therapy
- Another malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
- Porphyria
- Glucose- 6 phosphate dehydrogenase (G6PD) deficiency
- Alcoholic liver disease
- Any other concurrent severe/uncontrolled medical conditions
- Currently taking amiodarone
- Prior radiotherapy, chemotherapy, immunotherapy, biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumour-infiltrating lymphocytes, lymphokine-activated killer cell therapy, or gene therapy), or hormonal therapy for brain tumour
- Prior polifeprosan 20 with carmustine implant (Gliadel wafer) or GliaSite® brachytherapy
- Concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine)
- Other concurrent chemotherapeutic or investigational agents for this cancer (Concurrent glucocorticoids will be allowed
- Documented side effects to chloroquine or related agents.
- Unable to give informed consent
- Patients with a history of a psychological illness or condition that in the opinion of the investigator may adversely affect compliance with study medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: SCRT alone Radiotherapy Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy Arm B Hydroxychloroquine Patients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression.
- Primary Outcome Measures
Name Time Method 1 year Survival The survival rate will be calculated by the number of patients alive 1 year after entering the trial. The primary endpoint of the trial is survival at one year
- Secondary Outcome Measures
Name Time Method Toxicity Toxicity will be assessed during and up to 30 days after treatment Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.
Trial Locations
- Locations (15)
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Glan Clwyd Hospital
🇬🇧Bodelwyddan, United Kingdom
Norfolk & Norwich University Hospitals
🇬🇧Norwich, United Kingdom
Charing Cross Hospital
🇬🇧London, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Guy's and St Thomas's Hospitals
🇬🇧London, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
The Royal Preston Hospital
🇬🇧Preston, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom