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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)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 70 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01602588
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University College, London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Susan Short, Professor
Principal Investigator Affiliation St James's University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: 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.

Active Comparator: Arm A: SCRT alone

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

Interventions

Drug: - Hydroxychloroquine

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

Radiation: - Radiotherapy

Short Course radiotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

St James's University Hospital, Leeds, West Yorkshire, United Kingdom

Status

Address

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF

Glan Clwyd Hospital, Bodelwyddan, United Kingdom

Status

Address

Glan Clwyd Hospital

Bodelwyddan, , LL18 5UJ

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Address

Addenbrooke's Hospital

Cambridge, , CB2 0QQ

Ninewells Hospital, Dundee, United Kingdom

Status

Address

Ninewells Hospital

Dundee, ,

Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

Status

Address

Beatson West of Scotland Cancer Centre

Glasgow, , G12 0YN

Royal Surrey County Hospital, Guildford, United Kingdom

Status

Address

Royal Surrey County Hospital

Guildford, , GU2 7XX

University College Hospital, London, United Kingdom

Status

Address

University College Hospital

London, , NW1 2BU

Guy's and St Thomas's Hospitals, London, United Kingdom

Status

Address

Guy's and St Thomas's Hospitals

London, , SE1 9RT

Charing Cross Hospital, London, United Kingdom

Status

Address

Charing Cross Hospital

London, , w6 8RF

Christie Hospital, Manchester, United Kingdom

Status

Address

Christie Hospital

Manchester, , M20 4BX

James Cook University Hospital, Middlesbrough, United Kingdom

Status

Address

James Cook University Hospital

Middlesbrough, , TS4 3BW

Freeman Hospital, Newcastle, United Kingdom

Status

Address

Freeman Hospital

Newcastle, , NE7 7DN

Norfolk & Norwich University Hospitals, Norwich, United Kingdom

Status

Address

Norfolk & Norwich University Hospitals

Norwich, , NR4 7UY

The Royal Preston Hospital, Preston, United Kingdom

Status

Address

The Royal Preston Hospital

Preston, , PR2 9HT

Royal Stoke University Hospital, Stoke-on-Trent, United Kingdom

Status

Address

Royal Stoke University Hospital

Stoke-on-Trent, , ST4 6QG