Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma

Summary

Glioblastoma multiforme (GBM) is the most common brain tumor in adults. The strikingly poor survival for patients with GBM (average survival 14-16 months following diagnosis) is due in part to limited early detection methods and an absence of effective therapeutic options. The study proposed would establish important evidence for the use of Health Canada approved drugs such as amantadine as a safe, effective and affordable way to monitor GBM. The method is based on the overproduction of a key enzyme in GBM cells called spermine/ spermidine n-acetyl transferase (SSAT1). The increased SSAT1 expression in GBM results in increased metabolism of the drug which is detected in the blood or urine of patients with GBM. The levels of acetyl-amantadine captured will be correlated with the tumor burden as seen on the MRIs of these patients. Thus, the study aims to determine the usefulness of amantadine as a diagnostic biomarker for GBM.

Eligibility

Inclusion Criteria:

* Adult (18 years+)
* Pathologically confirmed Glioblastoma
* ECOG performance status 0-2
* Planned treatment with radiation and/or chemotherapy with temozolomide or lomustine
* Able to return to the study centre for study visits
* Able to swallow oral pills
* Serum creatinine and creatinine clearance (\>60mL/min)
* Liver enzymes for liver function (Liver function tests \<2.5 times the upper limit of normal)
* Participants of childbearing potential must agree to use an effective contraceptive method.

Exclusion Criteria:

* Known hypersensitivity or allergy to amantadine
* Concurrent infection requiring antiviral medication
* Concurrent medication with known interaction with amantadine (see below)
* Previous diagnosis of Parkinson's disease or parkinsonism
* Previous diagnosis of schizophrenia
* Current use of methamphetamine or cocaine
* Inability to swallow oral pills
* Significant impairment in renal function (Creatinine clearance \< 60 mL/min)
* Women who are pregnant or are breastfeeding

Conditions2

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