GlioblastomaPhase 2HCQNCT01602588
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)
A Phase 2 study testing Hydroxychloroquine and Radiotherapy in people with Glioblastoma, run by University College, London at 15 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Hydroxychloroquine and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- May 2013to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Glan Clwyd Hospital
Bodelwyddan, LL18 5UJ
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Ninewells Hospital
Dundee
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Royal Surrey County Hospital
Guildford, GU2 7XX
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
University College Hospital
London, NW1 2BU
Guy's and St Thomas's Hospitals
London, SE1 9RT
Charing Cross Hospital
London, w6 8RF
Christie Hospital
Manchester, M20 4BX
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle, NE7 7DN
Norfolk & Norwich University Hospitals
Norwich, NR4 7UY
The Royal Preston Hospital
Preston, PR2 9HT
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
About this study
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)
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.
- Conditions
- Glioblastoma
- Being tested
- Hydroxychloroquine, Radiotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called HCQ
200mg bd from 14 days post surgery until clinical or radiological progression
RadiotherapyRadiation
Short Course radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Experimental | Patients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression. Receives: Drug: Hydroxychloroquine |
| Arm A: SCRT alone | Active comparator | Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Survival
The primary endpoint of the trial is survival at one year
Measured: The survival rate will be calculated by the number of patients alive 1 year after entering the trial.
Secondary outcomes (1)
Toxicity
Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.
Measured: Toxicity will be assessed during and up to 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startMay 2013
- Primary completionOct 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Susan Short, Professor, Principal investigator, St James's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602588
- Sponsor's protocol ID
- UCL11/0404
- Acronym
- HCQ
- Status last verified
- May 2018
- First submitted
- 8 May 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01602588
- Acronym / sponsor ID
- HCQ / UCL11/0404
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- May 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Experimental | Drug: HydroxychloroquinePatients randomised to Arm B will receive Short Course Radiotherapy plus Hydroxychloroquine 200mg bd from 14 days post surgery until clinical or radiological progression. |
| Arm A: SCRT alone | Active comparator | Radiation: RadiotherapyPatients randomised to Arm A will receive standard treatment of Short Course Radiotherapy |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: HCQ200mg bd from 14 days post surgery until clinical or radiological progression | Drug | Arm B |
| RadiotherapyShort Course radiotherapy | Radiation | Arm A: SCRT alone |
Primary outcome
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
1 secondary outcome
Toxicity
Time frame: Toxicity will be assessed during and up to 30 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Short, Professor principal investigator
St James's University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine and Radiotherapy in people with Glioblastoma, run by University College, London at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Survival (time frame: The survival rate will be calculated by the number of patients alive 1 year after entering the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.