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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)

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ClinicalTrials.gov Identifier: NCT01602588
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 21, 2012
Last Update Posted Date May 3, 2018
Study Start Date  ICMJE May 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Hydroxychloroquine
    200mg bd from 14 days post surgery until clinical or radiological progression
    Other Name: HCQ
  • Radiation: Radiotherapy
    Short Course radiotherapy
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Hydroxychloroquine
  • Active Comparator: Arm A: SCRT alone
    Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
    Intervention: Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2012)
57
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01602588
Other Study ID Numbers  ICMJE UCL11/0404
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Cancer Research UK
Investigators  ICMJE
Principal Investigator: Susan Short, Professor St James's University Hospital
PRS Account University College, London
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP