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NCT Number: NCT01602588

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)

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St James's University Hospital, Leeds, West Yorkshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

200mg bd from 14 days post surgery until clinical or radiological progression

Other names: HCQ

Radiotherapy

Radiation

Short Course radiotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Cancer Research UK

Registry information

Official study 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)

Acronym: HCQ

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 21, 2012
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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