Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy

Launched by NATIONAL CANCER INSTITUTE (NCI) · May 15, 2019

Keywords

ClinConnect Summary

This clinical trial is focused on studying a substance called 2-hydroxyglutarate (2-HG) in the brains of people with gliomas, a type of brain cancer that can be more aggressive if it has certain gene mutations (specifically, mutations in the IDH1 or IDH2 genes). Researchers believe that understanding how 2-HG builds up in the brain could help in developing better ways to detect and manage gliomas.

To participate in this trial, individuals must be 18 years or older and have confirmed gliomas with the IDH1 or IDH2 mutations. Participants will undergo a series of tests, including medical history reviews, physical exams, and brain scans using MRI. After the initial evaluation, they will have follow-up visits every 2 to 6 months for ongoing monitoring. It's important to note that women who are pregnant or breastfeeding cannot participate due to potential risks. This study aims to provide valuable insights that could improve glioma diagnosis and treatment in the future.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • 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.
• EXCLUSION CRITERIA:
• • Participants who have contraindication to MRI examination, including, but not limited to, unable to receive gadolinium, medical instability, or any contraindication on MR Screening Form. Pregnant individuals are excluded because MRI contrast, planned to be used on this study, may be dangerous for the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to using of MRI contrast, breastfeeding should be discontinued for 72 hours following study imaging.
• • Participants weighing \> 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
• • Poorly controlled hypertension, with blood pressure \>150/90 mmHg.
• • Congestive heart failure with New York Heart Association (NYHA) status \> 2.
• • A medical history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) less than 1 year ago with ensuing unstable EKG.
• • Ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma with an exacerbation within the past year.