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)

Glioblastoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602588
• Other study ID #: UCL11/0404
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: November 2017

Study information

• Verified date: May 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

In this trial the investigators wish to investigate whether treatment with radiotherapy and hydroxychloroquine is more effective than treatment with radiotherapy alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Hydroxychloroquine
200mg bd from 14 days post surgery until clinical or radiological progression

Radiation:
• Radiotherapy
Short Course radiotherapy

Locations

Country	Name	City	State
United Kingdom	Glan Clwyd Hospital	Bodelwyddan
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	St James's University Hospital	Leeds	West Yorkshire
United Kingdom	Charing Cross Hospital	London
United Kingdom	Guy's and St Thomas's Hospitals	London
United Kingdom	University College Hospital	London
United Kingdom	Christie Hospital	Manchester
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Norfolk & Norwich University Hospitals	Norwich
United Kingdom	The Royal Preston Hospital	Preston
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year Survival	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	Toxicity	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