GBM-FLUX2: Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients
Study Details
Study Description
Brief Summary
To learn how altered metabolism in GBM causes tumor growth and resistance to drug therapy. In this pilot research study, we will dose GBM patients with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants in surgery Surgical removal of the GBM tumor. |
Procedure: Surgical removal of the GBM tumor
Surgical removal of the GBM tumor
Other: d4-NAM infusion
Following the surgical removal of the GBM tumor, GBM patients will be dosed with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq) [2 months]
Resected tumor tissue will undergo routine testing
Eligibility Criteria
Criteria
Inclusion Criteria:
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Preoperative MRI consistent with a primary intracranial malignant brain tumor.
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Must be 18 years of age or older.
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Patient eligible for debulking surgery/resection.
Exclusion Criteria:
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Inability to obtain pre-operative IV access.
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Use of Tru Niagen, Basis (or any other nicotinamide riboside (NR)-containing NAD+ booster) or niacin supplements within one month prior to Study Visit 1.
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Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1
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Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Study Visit 1 (participants may not donate blood any time during the study, through the final study day)
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Presence of any condition that, in the opinion of Dr. Field, compromises participant safety or data integrity or the participant's ability to complete study days.
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Pregnancy, lactation or < 9 months postpartum from the Study Visit 1 date.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AdventHealth Translational Research Institute | Orlando | Florida | United States | 32804 |
Sponsors and Collaborators
- AdventHealth Translational Research Institute
Investigators
- Principal Investigator: Stephen Gardell, PhD, AdventHealth Translational Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2063291