Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
CancerCare Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Anmol Mann, BSc.
manna34@myumanitoba.ca
2049959367
Time Frame
Start Date: 2020-12-02
Estimated Completion Date: 2025-08
Participants
Target number of participants: 20
Treatments
Experimental: GBM Patients
This cohort of patients will be asked to orally ingest 200mg dose of FDA approved drug amantadine hydrochloride. This will be done at the following timepoints:~1. Within 4 weeks of the start of treatment; but as close to commencement of treatment (Day 1 of radiotherapy) as possible for newly diagnosed patients.~2. Cycle 1, Day 1 of chemotherapy (temozolomide or lomustine) +/- 7 days~3. Day 1 +/- 7 days for each visit where MRI is obtained (typically every 8-12 weeks - pre-cycles 4, 7, 10, for temozolomide or pre-cycles 3, 5, and 7 for lomustine)
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), University of Manitoba, BioMark Diagnostics Inc., The Metabolomics Innovation Centre
Leads: CancerCare Manitoba

This content was sourced from clinicaltrials.gov