Clinical trial NCT01602588: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2012-05-21
Enrollment: 54
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 1 year Survival
timeFrame: The survival rate will be calculated by the number of patients alive 1 year after entering the trial.
Secondary outcomes:
measure: Toxicity
timeFrame: Toxicity will be assessed during and up to 30 days after treatment
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
city: Bodelwyddan
country: United Kingdom
facility: Glan Clwyd Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas's Hospitals
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospitals
city: Preston
country: United Kingdom
facility: The Royal Preston Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: St James's University Hospital
name: Susan Short, Professor
role: PRINCIPAL_INVESTIGATOR
References: