Phase 1 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:

• Adults aged 18 or older
• People whose brain tumor tissue tests positive for a specific genetic change called IDH1R132H
• People with a Grade 2 or Grade 3 glioma (a type of brain tumor) that has come back or grown, with a certain amount of tumor visible on scans that does not show signs of active blood vessel growth (confirm with trial site)
• People experiencing their first recurrence of the tumor only (not a second or later recurrence)
• People who have signed a consent form agreeing to take part
• Women who could become pregnant must have a negative blood pregnancy test before starting the trial
• Women who could become pregnant and male participants must agree to use contraception during the trial
• People with a Karnofsky Performance Status score of 70 or higher — a measure used by doctors to rate how well a person can carry out daily activities (confirm with trial site)
• People whose doctors expect them to live at least 12 months
• People who have recovered from any significant side effects of previous brain tumor surgery, or whose side effects are stable with medical treatment
• People with blood test results within acceptable ranges for bone marrow, kidney, and liver function, taken within 2 weeks of joining the trial (confirm with trial site)

Who may not be able to join:

• People who have had another type of cancer in the past (other than certain minor skin cancers), unless they have been cancer-free for 3 or more years — some very early-stage cancers may still be acceptable (confirm with trial site)
• People whose cancer has spread to certain areas at the base of the brain or outside the skull (confirm with trial site)
• People whose brain tumor scan shows more than a certain amount of actively growing (enhancing) disease on a specialised MRI scan
• People with serious active health conditions, including unstable chest pain or heart failure requiring hospitalisation, a heart attack within the past 6 months, AIDS as defined by current health authority guidelines, or serious medical or psychiatric conditions that the trial doctor believes would prevent safe completion of the treatment
• Women who are pregnant or breastfeeding
• People with certain heart rhythm abnormalities detected on an ECG, or other factors that increase the risk of heart rhythm problems such as heart failure or a family history of a specific heart condition (confirm with trial site)
• People with an active hepatitis B or hepatitis C infection — however, people who have successfully been treated for hepatitis C or have developed immunity to hepatitis B may still be eligible (confirm with trial site)
• People with active digestive system conditions that would make it difficult to take or absorb tablets by mouth, such as severe chronic diarrhoea, previous stomach removal surgery, or certain other gastrointestinal conditions — treated acid reflux is generally acceptable
• People currently taking certain medications that interact with the way the body processes the study drugs (confirm with trial site)
• People who have taken part in another treatment clinical trial within the 30 days before joining, or who would be doing so at the same time
• People with a known allergy to GM-CSF, yeast-based products, or any ingredient in the product Leukine®
• People with a known allergy to tetanus vaccine or any of its ingredients
• People with a known allergy to any ingredient in the study drug vorasidenib
• People who have previously been treated with a therapy targeting the same IDH1 gene mutation this trial is studying
• People who are unable to have an MRI scan

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