Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04530006|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : February 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Diagnostic Test: Amantadine Hydrochloride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients eligible for the study who have provided consent will be asked to ingest a regular 200mg dose of FDA approved drug Amantadine, according to timelines proposed in the protocol.|
|Masking:||None (Open Label)|
|Official Title:||Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2024|
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:
Diagnostic Test: 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:
- 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. ]Samples of plasma and urine will be analyzed by established analytical methods (as developed by Biopharmaceutical Research Inc., Vancouver, B.C.; Health Canada and FDA approved). Quantitative analysis of amantadine and acetyl-amantadine in plasma and urine samples will be performed using liquid chromatography triple quadrupole tandem mass spectroscopy (LC-MS/MS). Samples (50 µl) will be spiked with 50 µl of internal standard, deuterated acetyl-amantadine (d3-Ac-amantidine), and proteins precipitated with 0.5 ml of ice-cold methanol. The lyophilized deproteinated samples are reconstituted in 0.1 ml of 0.1% formic acid. Samples are injected onto a C-18 stationary column and eluted using a gradient mobile phase consisting of 0.1% aqueous formic acid (A) and 0.1% formic acid in methanol (B). The run time for each sample is 9 minutes with the mobile phase starting at 5% B and increasing to 95% B during sample elution.
- GBM tumor volume in correlation with serum 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. ]
Standard of care MRI will be used. Definitions of response to standard therapy (progression, stable disease, response) will follow the established Response Assessment in Neuro-Oncology (RANO) guidelines9.
Post-hoc volumetric analysis will be done using quantitative semi-automated Olea Sphere software (Olea Medical, France).
The study does not require additional MRI scans to be performed; Routine MRI images, as per glioblastoma standard of treatment, are posted to Radiology Information System/Picture Archiving and Communication System (RISPACS) and will be accessed for analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530006
|Contact: Anmol Mann, BSc.||firstname.lastname@example.org|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Contact: Gary Annable email@example.com|
|Principal Investigator: Marshall Pitz, MD, FRCPC|