Study of Niacin in Glioblastoma

Titre officiel

A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiation Therapy and Temozolomide Followed by Monthly Temozolomide

Sommaire:

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.

Description de l'essai

Primary Outcome:

• Determining the Maximum Tolerated Dose
• Evaluating if Niacin CRT Improves Glioblastoma Survival Rates

Secondary Outcome:

• Effect of Niacin CRT in Peripheral Monocytes
• Response Rate Associated with Niacin
• Overall Survival Rate Associated with Niacin
• Quality of Life While on Study using EORTC QLQ-C30 Questionnaires
• Quality of Life While on Study using EORTC BN-20 Questionnaires

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™.

Voir cet essai sur ClinicalTrials.gov