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)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2015 by University College, London
Sponsor:
University College, London
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01602588
First received: May 8, 2012
Last updated: December 7, 2015
Last verified: December 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: Hydroxychloroquine Radiation: Radiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by University College, London:
Primary Outcome Measures:
- 1 year Survival [ Time Frame: The survival rate will be calculated by the number of patients alive 1 year after entering the trial. ] [ Designated as safety issue: No ]The primary endpoint of the trial is survival at one year
Secondary Outcome Measures:
- Toxicity [ Time Frame: Toxicity will be assessed during and up to 30 days after treatment ] [ Designated as safety issue: Yes ]Adverse Events will be collected for all patients in the trial during treatment and up to 30 days afterwards.
| Estimated Enrollment: | 57 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 70 Years to 100 Years (Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602588
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602588
Contacts
| Contact: Ka Man Condne | 0207 679 9860 | ctc.hcq@ucl.ac.uk | |
| Contact: Alison Evans | 0207 679 9860 | ctc.hcq@ucl.ac.uk |
Locations
| United Kingdom | |
| St James's University Hospital | Recruiting |
| Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
| Principal Investigator: Susan Short, Professor | |
| Glan Clwyd Hospital | Recruiting |
| Bodelwyddan, United Kingdom, LL18 5UJ | |
| Principal Investigator: Win Soe, Dr | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, United Kingdom, CB2 0QQ | |
| Principal Investigator: Colin Watts, Dr | |
| Ninewells Hospital | Recruiting |
| Dundee, United Kingdom | |
| Principal Investigator: Hannah Lord, Dr | |
| Beatson West of Scotland Cancer Centre | Recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Principal Investigator: Anthony Chalmers, Professor | |
| Royal Surrey County Hospital | Recruiting |
| Guildford, United Kingdom, GU2 7XX | |
| Principal Investigator: Richard Shaffer, Dr | |
| University College Hospital | Recruiting |
| London, United Kingdom, NW1 2BU | |
| Principal Investigator: Naomi Fersht, Dr | |
| Guy's and St Thomas's Hospitals | Recruiting |
| London, United Kingdom, SE1 9RT | |
| Principal Investigator: Lucy Brazil, Dr | |
| Charing Cross Hospital | Recruiting |
| London, United Kingdom, w6 8RF | |
| Principal Investigator: Matthew Williams, Dr | |
| Christie Hospital | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Principal Investigator: Catherine McBain, Dr | |
| James Cook University Hospital | Recruiting |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Principal Investigator: Sarah Lawless, Dr | |
| Freeman Hospital | Recruiting |
| Newcastle, United Kingdom, NE7 7DN | |
| Principal Investigator: Joanne Lewis, Dr | |
| The Royal Preston Hospital | Recruiting |
| Preston, United Kingdom, PR2 9HT | |
| Principal Investigator: Stephen Kennedy, Dr | |
| Royal Stoke University Hospital | Recruiting |
| Stoke-on-Trent, United Kingdom, ST4 6QG | |
| Principal Investigator: Selvaraj Giridharan, Dr | |
| New Cross Hospital | Recruiting |
| Wolverhampton, United Kingdom, WV10 0QP | |
| Principal Investigator: Rozenn Allerton, Dr | |
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
| Principal Investigator: | Susan Short, Professor | St James's University Hospital |
More Information
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT01602588 History of Changes |
| Other Study ID Numbers: | UCL11/0404 |
| Study First Received: | May 8, 2012 |
| Last Updated: | December 7, 2015 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 27, 2016