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)
Overview
- Phase
- Phase 2
- Intervention
- Hydroxychloroquine
- Conditions
- Glioblastoma
- Sponsor
- University College, London
- Enrollment
- 54
- Locations
- 15
- Primary Endpoint
- 1 year Survival
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
Eligibility 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)
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
Arms & Interventions
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: Hydroxychloroquine
Arm A: SCRT alone
Patients randomised to Arm A will receive standard treatment of Short Course Radiotherapy
Intervention: Radiotherapy
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)