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)

NCT ID: NCT01602588

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-11-30

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B

Patients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression.

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

200mg bd from 14 days post surgery until clinical or radiological progression

Arm A: SCRT alone

Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: RADIATION

Short Course radiotherapy

Interventions

Hydroxychloroquine

200mg bd from 14 days post surgery until clinical or radiological progression

Intervention Type: DRUG

Radiotherapy

Short Course radiotherapy

Intervention Type: RADIATION

Other Intervention Names

HCQ

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Short, Professor

Role: PRINCIPAL_INVESTIGATOR

St James's University Hospital

Locations

St James's University Hospital

Leeds, West Yorkshire, United Kingdom

Glan Clwyd Hospital

Bodelwyddan, , United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

Ninewells Hospital

Dundee, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

Royal Surrey County Hospital

Guildford, , United Kingdom

University College Hospital

London, , United Kingdom

Guy's and St Thomas's Hospitals

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Norfolk & Norwich University Hospitals

Norwich, , United Kingdom

The Royal Preston Hospital

Preston, , United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Countries

United Kingdom

Other Identifiers

UCL11/0404

Identifier Type: -

Identifier Source: org_study_id