Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma
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This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus Dichloroacetate (DCA) improves overall survival and offers better control of the disease in patients with newly diagnosed Glioblastoma Multiforme Tumours.
Condition or disease
Drug: Dichloroacetate (DCA)
Patients with newly diagnosed Glioblastoma Multiforme Tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (TMZ) with DCA in pill form (twice a day) during the radiation phase of the study and then with TMZ for six months after. Other elements of the clinical trial include pharmacokinetics and MGMT genetic testing.
DCA starting at an initial dose of 3mg/kg twice daily PO for consecutive days (days 1-5) on a 28 days cycle up to 6 cycles unless evidence of tumour progression. Each dose to be administered with food at the same time everyday 12 hours apart.
Safety and tolerability of DCA in combination with radiotherapy and temozolomide in an adjuvant setting for the treatment of newly diagnosed GBM patients. [ Time Frame: 2 years ]
Secondary Outcome Measures :
To determine if there is a correlation between MGMT promoter methylation status and progression-free survival for newly diagnosed GBM patients undergoing concurrent TMZ, DCA and RT followed by six monthly cycles of TMZ and DCA [ Time Frame: 2 years ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
newly diagnosed GBM
Diagnosis must be established by open biopsy or tumour resection
Tumour must have a supratentorial component
Over 18 years
pre-treatment evaluations must be met
study therapy to begin within 6 weeks of surgery
KPS greater or equal to 70
patients must sign informed consent
If female, patients must not be pregnant or lactating
Women of childbearing potential and male participants must practice adequate contraception
prior invasive malignancy )except for non-melanomatous skin cancer) unless disease free for greater than 3 years
recurrent or multifocal malignant gliomas
metastatic disease of leptomeningeal spread
prior chemo or radiosensitizers for cancers of the head and neck region
prior RT to head and neck region except for T1 glottic cancer, resulting in overlap of radiation fields.
Severe active co-morbidity define in protocol
Pregnant of lactating women
Women of childbearing potential or men who are sexually active who are not willing or able to use medically acceptable forms of contraception; this exclusion is necessary due to the treatment involved potentially being teratogenic.
prior allergic reaction to temozolomide and/or dichloroacetate