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Diagnostic Biomarker

Amantadine as a Biomarker for Glioblastoma

N/A
Recruiting
Research Sponsored by CancerCare Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
Able to swallow oral pills
Must not have
Concurrent medication with known interaction with amantadine (see below)
Concurrent infection requiring antiviral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this outcome will be assessed every 8 to 12 weeks. this will continue through study completion, an average of two years.
Awards & highlights
No Placebo-Only Group

Summary

This trial uses the drug amantadine to help monitor brain tumors in patients with glioblastoma. By measuring how much of the drug is changed into another form in the body, doctors can track tumor activity. This could provide a better way to monitor these aggressive brain tumors.

Who is the study for?
This trial is for adults with confirmed Glioblastoma who are planning to undergo radiation and/or chemotherapy. They must be able to swallow pills, have good kidney and liver function, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with allergies to amantadine, drug abuse issues, severe kidney problems, Parkinson's disease or schizophrenia.
What is being tested?
The study tests if the drug Amantadine Hydrochloride can help monitor brain tumor burden in patients by measuring its metabolite levels in blood/urine against MRI results. It explores whether this method could serve as a new diagnostic biomarker for Glioblastoma.
What are the potential side effects?
While specific side effects of Amantadine Hydrochloride aren't listed here, common ones include dizziness, nausea, trouble sleeping and constipation. Patients may also experience confusion or hallucinations at higher doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I can swallow pills.
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I am scheduled for treatment with radiation and specific chemotherapy drugs.
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My liver function tests are within normal limits.
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I am 18 years old or older.
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My diagnosis is Glioblastoma.
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My kidney function, measured by creatinine levels, is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that interact with amantadine.
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I am currently taking antiviral medication for an infection.
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I am not pregnant or breastfeeding.
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My kidney function is reduced with a creatinine clearance rate below 60 mL/min.
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I have been diagnosed with Parkinson's disease or parkinsonism.
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I cannot swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this outcome will be assessed every 8 to 12 weeks. this will continue through study completion, an average of two years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome will be assessed every 8 to 12 weeks. this will continue through study completion, an average of two years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood and Urine Acetyl-Amantadine levels in patients with GBM
Secondary study objectives
GBM tumor volume in correlation with serum and urine acetyl-amantadine levels in patients with GBM

Side effects data

From 2010 Phase 2 & 3 trial • 184 Patients • NCT00970944
21%
Hypertonia / Spasticity
15%
Urinary tract infection
14%
Insomnia / Sleep Disturbance
14%
Agitation / Aggression
11%
Infections
10%
General Medical Problems
7%
Pneumonia
3%
Hydrocephalus
3%
Infection
2%
Other Gastrointestinal Problems
1%
Cardiac arrest
1%
Other Neurologic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amantadine HCL
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GBM PatientsExperimental Treatment1 Intervention
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amantadine Hydrochloride
2009
Completed Phase 3
~360

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Glioblastoma treatments often target the unique metabolic and genetic characteristics of the tumor cells. Amantadine, for example, is being studied for its potential as a diagnostic biomarker due to its metabolism by the SSAT1 enzyme, which is overexpressed in GBM cells. This overexpression leads to increased levels of acetyl-amantadine, which can be detected in blood or urine and correlated with tumor burden. Temozolomide, a standard chemotherapy drug, works by methylating DNA, thereby inducing cell death in rapidly dividing tumor cells. Radiation therapy damages the DNA of cancer cells, inhibiting their ability to replicate. These treatments are crucial for GBM patients as they offer ways to monitor and reduce tumor growth, potentially improving survival rates and quality of life.

Find a Location

Who is running the clinical trial?

The Metabolomics Innovation CentreUNKNOWN
University of ManitobaOTHER
618 Previous Clinical Trials
206,689 Total Patients Enrolled
1 Trials studying Glioblastoma
52 Patients Enrolled for Glioblastoma
CancerCare ManitobaLead Sponsor
28 Previous Clinical Trials
5,620 Total Patients Enrolled
1 Trials studying Glioblastoma
52 Patients Enrolled for Glioblastoma

Media Library

Amantadine Hydrochloride (Diagnostic Biomarker) Clinical Trial Eligibility Overview. Trial Name: NCT04530006 — N/A
Glioblastoma Research Study Groups: GBM Patients
Glioblastoma Clinical Trial 2023: Amantadine Hydrochloride Highlights & Side Effects. Trial Name: NCT04530006 — N/A
Amantadine Hydrochloride (Diagnostic Biomarker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530006 — N/A
~0 spots leftby Dec 2024