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)

This study is currently recruiting participants.
Verified May 2013 by University College, London
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01602588
First received: May 8, 2012
Last updated: May 13, 2013
Last verified: May 2013
  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 Primary Completion Date: May 2015 (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 and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602588

Contacts
Contact: Ka Man Condne 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         
Sponsors and Collaborators
University College, London
Cancer Research UK
  More Information

No publications provided

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: May 13, 2013
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 17, 2014