Glioblastoma
Conditions
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.
Interventions
DRUGHydroxychloroquine
200mg bd from 14 days post surgery until clinical or radiological progression
RADIATIONRadiotherapy
Short Course radiotherapy
Sponsors
Cancer Research UK
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed