NCT01602588CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University College, London
- Enrollment
- 54
- Locations
- 15
- Primary Endpoint
- 1 year Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to 100 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm B
Experimental
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: Hydroxychloroquine (Drug)
Arm A: SCRT alone
Active Comparator
Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
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
- Toxicity(Toxicity will be assessed during and up to 30 days after treatment)
Investigators
Study Sites (15)
Loading locations...
Similar Trials
Recruiting
Phase 2
Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)Alport Syndrome, X-LinkedNCT04937907Shanghai Children's Hospital50
Terminated
Phase 2
A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving RadiotherapyCOVID-19CancerNCT04381988Memorial Sloan Kettering Cancer Center4
Withdrawn
Phase 2
Evaluation of Hydroxychloroquine to Prevent CIPNBreast CancerGynecologic CancerEarly-stage Breast CancerChemotherapy-induced Peripheral NeuropathyPeripheral NeuropathyNCT05689359University of Arizona
Completed
Phase 1
Hydroxychloroquine and Bortezomib in Treating Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00568880Abramson Cancer Center at Penn Medicine25
Unknown
Phase 3
A Study of Hydroxychloroquine and Zinc in the Prevention of COVID-19 Infection in Military Healthcare WorkersSars-CoV2COVID19NCT04377646Military Hospital of Tunis660