Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Glioblastoma Multiforme Clinical Trial

— GBM-FLUX2  

Official title:

Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054529
• Other study ID #: 2063291
• Status: Recruiting
• Start date: September 11, 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: AdventHealth Translational Research Institute
• Contact: Stephen Gardell, PhD
• Phone: 407-303-7100
• Email: stephen.gardell[@]adventhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Preoperative MRI consistent with a primary intracranial malignant brain tumor.

2. Must be 18 years of age or older.

3. Patient eligible for debulking surgery/resection.

Exclusion Criteria:

1. Inability to obtain pre-operative IV access.

2. 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.

3. Participation in studies involving investigational drug(s) within 30 days prior to Study Visit 1

4. 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)

5. 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.

6. Pregnancy, lactation or < 9 months postpartum from the Study Visit 1 date.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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.

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subtyping of GBM tumors as Classical, Proneural or MES (based on RNA-seq)	Resected tumor tissue will undergo routine testing	2 months