This is a single institution Phase I-II study to evaluate the tolerability and Maximum Tolerated Dose (MTD) (Phase I) and efficacy (Phase II) of adding Niacin CRT™ to standard first line treatment (concurrent Radiation Therapy (RT) and Temozolomide (TMZ) following by monthly TMZ - AKA Stupp protocol) in patients with newly diagnosed glioblastoma isocitrate dehydrogenase (IDH) wild type.
During the Phase I stage Niacin CRT™ dose will be escalated every 4 weeks until the maximum tolerated dose (MTD) is determined. The MTD dose will be prescribed to patients during the Phase II stage. During the Phase I study a sample of blood at baseline, at each level dose of Niacin CRT™, and every two months during the maintenance phase while on Niacin CRTTM will be sent to a lab to evaluate the peripheral activity of Niacin CRT™ in innate immune system cells. These samples will be taken at the time of routine standard of care lab work. Based on prior clinical trials evaluating niacin extended release formulation for the management of dyslipidaemias there is vast experience on dose escalation of niacin. One of the main side effects is flushing that is ameliorated by escalating doses in intervals no shorter than 4 weeks and usually decreases with time. Following this schema, there is no increase in dose coinciding with TMZ while administered in a 5/28 days schedule (given daily for 5 days of each 28-day cycle). This will not only improve tolerance but also will allow us to differentiate potential adverse events from chemotherapy from the ones from Niacin CRT™.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
A controlled release technology (CRT) tablet of Niacin
Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Determining the Maximum Tolerated Dose
To evaluate and determine maximum tolerated dose (MTD) of Niacin CRT added to concurrent radiotherapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB).
Time frame: Up to 24 weeks after registration onto the study
Evaluating if Niacin CRT Improves Glioblastoma Survival Rates
To evaluate if adding Niacin CRT to current standard first line treatment of GB improves progression free survival (PFS) at 6 months.
Time frame: 6 months after determining the maximum tolerated dose which can last up to 24 weeks after registration onto the study
Effect of Niacin CRT in Peripheral Monocytes
To evaluate the effect of Niacin CRT in peripheral monocytes by comparing control monocytoid cells to those that have been treated with Niacin.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Response Rate Associated with Niacin
To determine the response rate associated with the investigational regimen.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Overall Survival Rate Associated with Niacin
To determine the overall survival (OS) associated with the investigational regimen.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quality of Life While on Study using EORTC QLQ-C30 Questionnaires
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To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC QLQ-C30 questionnaires.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quality of Life While on Study using EORTC BN-20 Questionnaires
To determine Quality of Life (QOL) that will be evaluated throughout the study using EORTC BN-20 questionnaires.
Time frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 5 years.