Using amantadine to monitor glioblastoma progression
Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma
This study is testing if measuring a substance called acetyl-amantadine in blood or urine can help track the progression of glioblastoma in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CancerCare Manitoba Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT04530006 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of acetyl-amantadine as a potential biomarker for monitoring glioblastoma multiforme (GBM) in patients. It focuses on the enzyme spermine/spermidine n-acetyl transferase (SSAT1), which is overproduced in GBM cells, leading to increased metabolism of amantadine. By measuring the levels of acetyl-amantadine in blood or urine, the study aims to correlate these levels with tumor burden as assessed by MRI. The goal is to establish a safe and effective method for early detection and monitoring of GBM progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically confirmed glioblastoma who are scheduled for radiation and/or chemotherapy.
Not a fit: Patients with known hypersensitivity to amantadine or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and non-invasive method for monitoring glioblastoma progression, potentially improving patient outcomes.
How similar studies have performed: While the use of biomarkers in cancer monitoring is a growing field, this specific approach using acetyl-amantadine in glioblastoma is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winnipeg, Manitoba
- CancerCare Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Anmol Mann, BSc.
- Email: manna34@myumanitoba.ca
- Phone: 2049959367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.