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Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
10/05/2013
Funder:
Cancer Research UK
Sponsor:
UCL
Chief Investigator:
Professor Susan Short
Recruitment target:
57
EudraCT number:
2012-000091-41
Contact details:
ctc.hcq@ucl.ac.uk
Lay summary:
HCQ
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)
Description
Design: HCQ is a randomised (2:1), multicentre, phase II study comparing hydroxychloroquine (HCQ) and short course radiotherapy (SCRT) with SCRT alone to examine the effect on one-year survival in patients aged 70 years and older with high grade gliomas.
Treatment: Patients randomised to receive HCQ will commence treatment twice daily between day 14 – 20 post-surgery until radiological or clinical progression. All patients are randomised to receive 6 fractions of SCRT (total 30 Gy). Patients are then followed up every 4 weeks until 12 weeks then 2 monthly until death.
Key inclusion/exclusion criteria:
Inclusion
  • Age ≥ 70 years
  • Histological diagnosis of high grade glioma 
  • Life expectancy > 2 months
  • ECOG 0-1
  • Adequate hepatic, renal and haematological function
  • MMSE ≥17

Exclusion
  • Concurrent uncontrolled or unstable psoriasis
  • Macular degeneration or diabetic retinopathy
  • Concurrent serious infection or medical illness that would preclude study therapy
  • Other malignancy within the past 5 years (with exceptions)
  • Porphyria
  • G6PD deficiency
  • Alcoholic liver disease
  • Currently taking amiodarone
  • Prior radiotherapy, chemotherapy, immunotherapy and biologic agents 
  • Prior polifeprosan 20 with carmustine implant or GliaSite® brachytherapy
  • Concurrent cytochrome P450 enzyme inducing anticonvulsant drugs
  • Documented side effects to chloroquine or related agents

Duration of recruitment: 2 years 
Aim
The trial will offer a new treatment approach to a group of patients who are often excluded from clinical protocols based on age. Since this is an increasing proportion of the newly diagnosed glioma population it will increase the proportion of all brain tumour patients who are included in clinical studies. If these data suggest that hydroxychloroquine may be an active agent in improving survival in glioma it could become an additional adjuvant treatment for other patient groups.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
NameVersionCurrent versRelease dateDownload
HCQ study protocol2 Current 11/08/2014
Trial documents
NameTypeVersionCurrent versRelease dateDownload
ISF documentsCollectionn/a Current 05/05/2017
PSF documentsCollectionn/a Current 05/05/2017
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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