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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 2
70 Years
N/A
Open (Enrolling)
Both
Glioblastoma

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1 year Survival

Outcome Description:

The primary endpoint of the trial is survival at one year

Outcome Time Frame:

The survival rate will be calculated by the number of patients alive 1 year after entering the trial.

Safety Issue:

No

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

UCL11/0404

NCT ID:

NCT01602588

Start Date:

May 2013

Completion Date:

Related Keywords:

  • Glioblastoma
  • Glioblastoma

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