Recruiting

Acetyl-Amantadine

Sponsor:

CancerCare Manitoba

Code:

NCT04530006

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amantadine Hydrochloride

Study Details

Brief 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.

Conditions

Glioblastoma Multiforme

Study ID

NCT04530006

Start date

Dec 2, 2020

Status verified date

Feb, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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)

Interventions

Amantadine Hydrochloride

Patients who are eligible for the study will be administered a regular 200 mg dose of FDA approved drug amantadine. 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)

Primary outcome measure

  • Blood and Urine Acetyl-Amantadine levels in patients with GBM [ Time Frame: This outcome will be assessed every 8 to 12 weeks. This will continue through study completion, an average of two years. ]

Central Contacts and Locations

Central contacts

Anmol Mann, BSc.

2049959367manna34@myumanitoba.ca

Locations

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Gary Annable

gannable@cancercare.mb.ca

Principal Investigator:

Marshall Pitz, MD, FRCPC

More Information

Sponsor

CancerCare Manitoba

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Keywords

  • Acetyl-amantadine
  • GBM
  • Glioblastoma
  • Brain
  • diagnostic biomarker
  • MRI
  • tumor volume
  • amantadine
  • brain tumor
  • cancer patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CancerCare Manitoba on 2024-02-23.