A Randomised Phase 2 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)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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