What side effects are associated with this type of intervention?

Common treatments for Glioblastoma include radiation therapy, chemotherapy (such as temozolomide), and investigational therapies like ONC201. Radiation therapy can cause side effects such as fatigue, hair loss, and skin changes. Temozolomide may lead to nausea, vomiting, fatigue, and increased risk of infection due to lowered blood cell counts. Investigational therapies like ONC201, which target specific molecular pathways, may have side effects including gastrointestinal disturbances and fatigue. While specific side effects of Amantadine in GBM are not detailed, its use in other conditions has been associated with dizziness, insomnia, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is an oral alkylating agent used in combination with radiation therapy, and bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF) for recurrent GBM. While these treatments do not specifically target the SSAT1 enzyme like the proposed use of Amantadine, they represent the current standard of care aimed at slowing tumor progression and managing symptoms.

What other types of research exist?

Promising novel alternatives to Amantadine for Glioblastoma patients in 2024 include: 1) Tumor Treating Fields (TTFields) - a non-invasive treatment that uses electric fields to disrupt cancer cell division. 2) CAR T-cell therapy - a form of immunotherapy that modifies a patient's T-cells to target and kill GBM cells. 3) Oncolytic virus therapy - uses genetically modified viruses to infect and kill cancer cells while stimulating an immune response. 4) Targeted therapies such as EGFR inhibitors (e.g., Osimertinib) and IDH1/2 inhibitors (e.g., Ivosidenib) which target specific mutations in GBM cells. These alternatives are in various stages of clinical trials and show potential for improving outcomes in GBM patients.

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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 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.

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

Pneumonia

Hydrocephalus

Infection

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

0 / 13Eligibility criteria met

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.