Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a type of brain tumour called diffuse glioma (WHO grades 2–4), confirmed by tissue testing at the NCI Laboratory of Pathology.
• People whose tumour has a specific genetic change called an IDH1 or IDH2 mutation, confirmed by a specific genetic test or prior documentation.
• People who have already received prior treatment for their brain tumour, such as radiation, chemotherapy, or a drug called vorasidenib, before their disease got worse.
• People whose glioma has come back (recurred), confirmed either by tissue testing or brain imaging.
• People who have previously had surgery to remove part or all of their tumour (eligible for cohorts 1–4).
• People who are older than 15 years of age.
• People who have a general health and functioning score (called the Karnofsky score) above 70%, meaning they are able to carry out normal activity with some effort (confirm with trial site).
• People whose blood tests show that their bone marrow, liver, and kidneys are working well enough to meet the trial's specific laboratory thresholds (confirm with trial site).
• People who have recovered well enough from the side effects of previous treatments, with any remaining effects being mild or moderate.
• People who are able to become pregnant, and male participants, who agree to use highly effective birth control during the study and for 3 months after the last dose of the study drug.
• People who are breastfeeding and are willing to stop breastfeeding from the start of treatment until 3 months after treatment ends.
• People who are scheduled to have a brain tumour biopsy or surgical removal at the NIH (this applies to cohort 5 only).
• People (or, for younger participants, their parent or legal guardian) who are able to understand and sign a written consent form — noting that a legal representative cannot provide the initial consent on someone's behalf.

Who may not be able to join:

• People in the Phase II part of the trial who have had more than one disease relapse if their original diagnosis was WHO grade 3–4 glioma, or more than two relapses if their original diagnosis was WHO grade 2 glioma (there are no limits on prior relapses for the Phase I part).
• People who received certain prior treatments too recently before starting the trial, including: any experimental drug or standard chemotherapy within the last 28 days; a drug called vincristine within the last 14 days; a type of chemotherapy called nitrosoureas within the last 42 days; a drug called procarbazine within the last 21 days; certain non-chemotherapy drugs (such as interferon, tamoxifen, thalidomide, or cis-retinoic acid) within the last 7 days; surgery within the last 14 days; or radiation therapy within the last 30 days.
• People who have previously been treated with a drug called bevacizumab specifically to treat their tumour (note: people who received bevacizumab only to manage symptoms such as brain swelling may still be eligible — confirm with trial site).
• People whose heart electrical activity test (ECG) shows a specific abnormality called a prolonged QTc interval above 470ms.
• People who have had another type of invasive cancer within the past 3 years, with some exceptions such as certain skin cancers or early-stage cancers that did not require systemic treatment (confirm with trial site).
• People who have had a serious allergic reaction to drugs chemically similar to the study drug zotiraciclib, such as a drug called flavopiridol.
• People who are currently pregnant, confirmed by a pregnancy test at screening.
• People with uncontrolled ongoing illness or personal circumstances that would make it difficult to follow the trial's requirements.
• People with uncontrolled type 1 diabetes.

Important: Always verify eligibility with the trial site directly before applying.