Studying the Biology of Higher-Grade Transformation in IDH-mutant Gliomas Via Longitudinal Observation of Tumor Metabolic Reprogramming Using Non-invasive Metabolic Imaging

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Background: Glioma is a type of brain cancer. Some of these tumors have gene mutations. These mutations can cause a substance called 2-HG to build up in the brain. This makes the tumors more aggressive. Researchers want to better understand 2-HG buildup in the brain. They hope this can help them design better ways to test for gliomas.

Objective: To monitor the level of 2-HG in the brains of people with gliomas that have mutations in the IDH1 or IDH2 genes.

Eligibility: People ages 18 and older with gliomas with mutations in the IDH1 or IDH2 genes

Design: Participants will be screened with: Medical and cancer history Physical exam Reviews of their symptoms and ability to perform normal activities Blood and urine tests MRI scan Samples of their tumor from a past surgery Documentation of their diagnosis and mutation status Participants will have an initial evaluation. This will include repeats of screening tests. It will also include: Neurological exam MRS and MRI scans of the brain: Participants will lie on a table that slides into a metal cylinder. A coil or soft padding will be placed around their head. They will have a contrast agent injected into a vein. Pictures will be taken of the brain. Participants will have follow-up visits every 2-6 month for the rest of their life. Visits will include scans.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

⁃ Participants must have histologically confirmed diffuse glioma with documented IDH1 or IDH2 mutation, confirmed by DNA sequencing the exception will be participants with brain lesions that are not safe for biopsy but clinically suspected to be diffuse glioma are allowed to enroll to the study to receive imaging study as part of the exploratory study

⁃ Participants must have measurable disease.

⁃ Age \>=18 years. Tumor biology of IDH-mutant gliomas are different in pediatric tumors. Therefore, children will be excluded from the study.

⁃ Karnofsky performance \>= 70%.

⁃ Participants must have documented normal kidney function as defined below:

‣ Creatinine within normal institutional limits

‣ OR

‣ Creatinine clearance \>60 mL/min/1.73 m2 for Participants with creatinine levels above institutional normal (Measured or calculated creatinine clearance

• Participants must have adequate liver function as defined below:

‣ total bilirubin \<=2x ULN (ULN 1.3 mg/dl) except for participants with Gilbert Syndrome

‣ AST \< 3x ULN (ULN 34U/L)

‣ ALT \< 3x ULN (ULN 55U/L)

• Ability of participants to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study, and that this is not a therapeutic clinical trial.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
NCI NOB Referral Group
ncinobreferrals@mail.nih.gov
(866) 251-9686
Backup
Jing Wu, M.D.
jing.wu3@nih.gov
(240) 760-6036
Time Frame
Start Date: 2019-10-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 270
Treatments
Experimental: 1/Arm 1
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS) -- THIS ARM IS NOW CLOSED
Experimental: 2/Arm 2
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS) and HP 13C pyruvate MRSI
Experimental: 3/Arms 3
Monitoring of quantitative levels of 2-hydroxyglutarate (2-HG) via proton magnetic resonance spectroscopy (1H-MRS)
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov