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:

• People who have been diagnosed with ependymoma, medulloblastoma, glioblastoma, or another type of primary brain or spinal cord cancer that has come back or stopped responding to treatment, and for which no standard curative treatment options remain.
• People whose cancer has spread to other parts of the body may still be considered.
• People who have had a recent MRI scan (with and without contrast dye) confirming the cancer is currently active.
• People who are able to swallow pills.
• People whose general health and ability to function meets a minimum score on a standard medical scale (≥ 50% on the Lansky or Karnofsky scale — confirm with trial site what this means for your situation).
• People whose kidneys are working at an adequate level, based on blood test results.
• People whose liver is working at an adequate level, based on blood test results.
• People whose blood cell counts (white blood cells, platelets, and haemoglobin) are at adequate levels without needing recent support from growth factor injections or blood transfusions.
• People with seizures that are well managed with anti-seizure medication.
• People who have previously received chemotherapy drugs included in this trial's treatment plan may still be considered.
• People who have waited at least 21 days since their last chemotherapy or other investigational treatment (other than indoximod) before the screening visit.
• People who have waited at least 28 days since their last treatment involving antibody-based therapies, cancer vaccines, or immune cell therapies before the screening visit.
• People who have waited at least 56 days since their last treatment using infectious agents (such as viruses or bacteria) directed at the tumour before the screening visit.
• People who have waited at least 90 days since radiation or proton therapy that targeted all known sites of disease before the screening visit.
• People who received radiation that only targeted some disease sites (not all) may be considered without a required waiting period, provided at least one active tumour site is expected to remain or grow (confirm with trial site).
• People who are not receiving any other cancer treatments while enrolled in this trial.
• Women who could become pregnant and men who are sexually active must be using a highly effective form of contraception during and after the trial; men must also agree not to donate sperm during the trial and for 3 months after.
• People who are willing to sign a consent form (or, for those under 18, whose parent or guardian is willing to sign) confirming they understand and agree to take part.

Who may not be able to join:

• People who are unable to swallow pills.
• People who have a known allergy or sensitivity to any of the drugs used in this trial's treatment plan.
• People who have an active autoimmune disease that requires ongoing medical treatment (note: common allergic conditions such as eczema or asthma would not automatically exclude someone — confirm with trial site).
• Women who are pregnant or breastfeeding.
• People who have had major surgery or have a wound that has not fully healed within 4 weeks before the screening visit.
• People with a known diagnosis of central nervous system lymphoma.
• People who have had active bleeding, a blood clot–related stroke, a bleeding stroke, or bleeding in the brain within the past 6 months (with some exceptions for bleeding related to recent routine brain surgery — confirm with trial site).
• People who need to take warfarin or similar blood-thinning medications.
• People who need ongoing treatment with certain strong medications that affect how the liver processes drugs (strong CYP3A inhibitors — confirm with trial site which medications this includes).
• People with significant heart problems, such as uncontrolled or symptomatic irregular heartbeat, heart failure, or a heart attack within the past 6 months, or moderate-to-severe heart disease as classified by standard medical guidelines.
• People with a specific heart rhythm measurement (QTc interval) that is too long on a heart tracing (ECG), or who have an inherited condition called long QT syndrome.
• People who have received a live vaccine within 4 weeks before the screening visit.
• People with a known history of HIV, or currently active Hepatitis B or Hepatitis C infection, or any other uncontrolled active infection.
• People with any other serious illness or medical condition that, in the opinion of the trial doctor, could put them at risk or interfere with how the trial medications are processed by the body.

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