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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) (HCQ)

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ClinicalTrials.gov Identifier: NCT01602588
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Study Description
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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.


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Hydroxychloroquine Radiation: Radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Hydroxychloroquine
200mg bd from 14 days post surgery until clinical or radiological progression
Other Name: HCQ
Active Comparator: Arm A: SCRT alone
Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
 Radiation: Radiotherapy
Short Course radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 1 year Survival [ Time Frame: 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 Outcome Measures :
  1. Toxicity [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602588


Locations
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United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Glan Clwyd Hospital
Bodelwyddan, United Kingdom, LL18 5UJ
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Ninewells Hospital
Dundee, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Royal Surrey County Hospital
Guildford, United Kingdom, GU2 7XX
University College Hospital
London, United Kingdom, NW1 2BU
Guy's and St Thomas's Hospitals
London, United Kingdom, SE1 9RT
Charing Cross Hospital
London, United Kingdom, w6 8RF
Christie Hospital
Manchester, United Kingdom, M20 4BX
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Norfolk & Norwich University Hospitals
Norwich, United Kingdom, NR4 7UY
The Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
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Principal Investigator: Susan Short, Professor St James's University Hospital
More Information
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01602588    
Other Study ID Numbers: UCL11/0404
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents