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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
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
Study Summary
This trial is testing whether or not a drug called amantadine could be used to help monitor brain tumors called glioblastomas.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood and Urine Acetyl-Amantadine levels in patients with GBM
Secondary outcome measures
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 • NCT0097094421%
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
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:
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.
Cycle 1, Day 1 of chemotherapy (temozolomide or lomustine) +/- 7 days
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
Find a Location
Who is running the clinical trial?
The Metabolomics Innovation CentreUNKNOWN
University of ManitobaOTHER
595 Previous Clinical Trials
199,506 Total Patients Enrolled
1 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
CancerCare ManitobaLead Sponsor
28 Previous Clinical Trials
5,648 Total Patients Enrolled
1 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that interact with amantadine.I can visit the study center for follow-up appointments.You have been diagnosed with schizophrenia in the past.I can take care of myself and am up and about more than half of my waking hours.I am currently taking antiviral medication for an infection.I can swallow pills.You have a known allergy or sensitivity to amantadine.I am scheduled for treatment with radiation and specific chemotherapy drugs.My liver function tests are within normal limits.I am 18 years old or older.I am not pregnant or breastfeeding.My kidney function is reduced with a creatinine clearance rate below 60 mL/min.I have been diagnosed with Parkinson's disease or parkinsonism.My diagnosis is Glioblastoma.My kidney function, measured by creatinine levels, is normal.I cannot swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: GBM Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this project presently seeking participants?
"Clinicaltrials.gov states that this trial is actively seeking participants, with the initial post being made on December 2nd 2020 and an update most recently occurring on March 4th 2022."
Answered by AI
What is the cap on patient involvement in this research endeavor?
"Affirmative, the information hosted on clinicaltrials.gov indicates that recruitment for this medical study is still ongoing. The trial was originally posted on December 2nd 2020 and last updated March 4th 2022. 20 participants are required from a single site to complete enrolment in the research project."
Answered by AI
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