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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)

Primary Purpose

Glioblastoma

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Hydroxychloroquine
Radiotherapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St James's University Hospital
  • Glan Clwyd Hospital
  • Addenbrooke's Hospital
  • Ninewells Hospital
  • Beatson West of Scotland Cancer Centre
  • Royal Surrey County Hospital
  • University College Hospital
  • Guy's and St Thomas's Hospitals
  • Charing Cross Hospital
  • Christie Hospital
  • James Cook University Hospital
  • Freeman Hospital
  • Norfolk & Norwich University Hospitals
  • The Royal Preston Hospital
  • Royal Stoke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm B

Arm A: SCRT alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

1 year Survival
The primary endpoint of the trial is survival at one year

Secondary Outcome Measures

Toxicity
Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.

Full Information

First Posted
May 8, 2012
Last Updated
May 2, 2018
Sponsor
University College, London
Collaborators
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT01602588
Brief Title
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)
Acronym
HCQ
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Cancer Research UK

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm B
Arm Type
Experimental
Arm Description
Patients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression.
Arm Title
Arm A: SCRT alone
Arm Type
Active Comparator
Arm Description
Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
HCQ
Intervention Description
200mg bd from 14 days post surgery until clinical or radiological progression
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Short Course radiotherapy
Primary Outcome Measure Information:
Title
1 year Survival
Description
The primary endpoint of the trial is survival at one year
Time Frame
The survival rate will be calculated by the number of patients alive 1 year after entering the trial.
Secondary Outcome Measure Information:
Title
Toxicity
Description
Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.
Time Frame
Toxicity will be assessed during and up to 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Short, Professor
Organizational Affiliation
St James's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Bodelwyddan
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Guy's and St Thomas's Hospitals
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
w6 8RF
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospitals
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
The Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

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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)

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