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)

Phase 1

• Conditions: High Grade glioma; MedDRA version: 17.0 Level: PT Classification code 10018338 Term: Glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000091-41-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-10
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

•Male and female patients aged =70 yrs identified through the neuro-oncology 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 10^9 L
•Platelet count = 100 x 10^9 L
•Bilirubin = 1.5 mg/dL (or = 25.6 micromol/L)
•Creatinine = 2 times upper limit of normal (ULN)
•ALT and AST = 4 times ULN
•Mini Mental Status Exam score = 17
•Written informed consent
•Ready to start radiotherapy within 4 weeks of surgery
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified