A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide
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.
• Adults, 18 years old to 75 years old inclusive.
• New diagnoses of glioblastoma IDH wild type.
• ECOG 0-2 (Appendix I).
• Candidates for concurrent standard first line treatment according to their Neuro-Oncologist and Radiotherapy Oncologist after maximal safe debulking neurosurgery. Patients that only had biopsy are included as long as pathology confirms the diagnoses and it is considered the maximal safe procedure for that patient.
• Adequate hematological, renal and hepatic function (see details in Section 4.1 of the protocol).
• Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B or hepatitis C infection.
• Absence of any other serious medical condition according to the medical judgment of the Qualified Investigator prior to registration.
• Absence of any medical condition, which could interfere with oral medication intake.
• Signed informed consent.
• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre.
• Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.