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)

May 2, 2018 updated by: University College, London

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bodelwyddan, United Kingdom, LL18 5UJ
        • Glan Clwyd Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
      • Dundee, United Kingdom
        • Ninewells Hospital
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, NW1 2BU
        • University College Hospital
      • London, United Kingdom, SE1 9RT
        • Guy's and St Thomas's Hospitals
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospitals
      • Preston, United Kingdom, PR2 9HT
        • The Royal Preston Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James's University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 96 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The survival rate will be calculated by the number of patients alive 1 year after entering the trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Toxicity will be assessed during and up to 30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Cancer Research UK

Investigators

  • Principal Investigator: Susan Short, Professor, St James's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 17, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL11/0404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma

Clinical Trials on Hydroxychloroquine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe