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 are at least 18 years old.
• People who are able to understand the study's purpose and risks, and have signed a consent form approved by the relevant ethics committee.
• People who have been diagnosed through a tissue biopsy with a Grade III or IV recurrent glioma (such as Astrocytoma IDH-mutant grade 3 or 4, or Glioblastoma IDH-wildtype grade 4), confirmed according to 2021 WHO brain tumour classifications.
• People whose brain tumour has come back and shown signs of growth after receiving standard treatments (such as surgery, chemotherapy, radiation, or tumour treating fields), or who are medically unable or unwilling to undergo those standard treatments.
• People taking anti-seizure medications whose dose has been stable for at least two weeks with no seizures before the study begins.
• People taking corticosteroids (steroid medications to reduce brain swelling) whose dose has been stable or reducing for at least two weeks, with no worsening symptoms, before the study begins.
• People whose tumour falls within the area that the treatment is designed to reach.
• People with a general health status rated as ECOG 0–2 or a Karnofsky score of 60 or above (meaning able to carry out some self-care and daily activities — confirm with trial site if unsure what this means for a specific situation).
• People with a life expectancy of at least 2 months.
• People whose liver function blood test results are within acceptable ranges (confirm with trial site).
• People whose kidney function blood test results are within acceptable ranges (confirm with trial site).
• People whose blood counts (white blood cells, platelets, and haemoglobin) are within acceptable ranges without the need for blood support (confirm with trial site).
• Women who could become pregnant must have a negative blood pregnancy test before joining, and both men and women must agree to use effective contraception from the time of joining the trial until 6 months after the last dose.

Who may not be able to join:

• People who show signs of recent active bleeding in or around the brain on an MRI or CT scan (people with minor resolved bleeding changes may still be considered — confirm with trial site).
• People who are unable to have an MRI scan, for example due to having a pacemaker or being medically unstable.
• People who have not yet recovered from significant side effects of previous cancer treatments (with the exception of hair loss, anaemia, or low lymphocyte counts).
• People who are pregnant or breastfeeding.
• People with serious ongoing health conditions that the treating doctor determines could affect patient safety or study results, including:
  • Uncontrolled high blood pressure despite treatment
  • Active serious infection not responding to antibiotics, an unhealed wound or ulcer, uncontrolled systemic infection, or bone fracture
  • Significant heart rhythm problems not controlled by medication
  • Untreated underactive thyroid
  • Heart failure or unstable chest pain within the past 3 months
  • A heart attack, stroke, or mini-stroke within the past 6 months
  • Another active cancer (other than the glioma), excluding certain minor skin cancers or early-stage cervical changes, unless the treating doctor determines it would not affect safety or study results
• People with an inherited condition that affects blood clotting or causes a risk of bleeding.
• People who have previously received any of the following treatments:
  • The drug Bevacizumab
  • Certain non-standard forms of radiation therapy (such as brachytherapy, radioactive substances given systemically, or radiation given during surgery) to the target area
  • Any radiation therapy within 12 weeks before screening
  • Certain systemic drug treatments or hormonal therapies within specific timeframes before the study starts (confirm with trial site for exact timeframes)
  • Biological therapies such as antibodies, immune-modulating drugs, vaccines, or cytokines within 21 days before the study starts
  • Certain chemotherapy types within specific timeframes before the study starts (confirm with trial site for exact timeframes)
  • Carmustine wafers implanted in the brain
  • Any other experimental treatment currently or within 28 days before the study starts
• People whose tumour has spread to multiple areas or has spread to the lining of the brain or spinal cord.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the study's requirements.
• People whose tumour is located in the lower part of the brain below the main brain structures (called infratentorial disease — confirm with trial site).
• People whose tumour is located within 1–2 cm of a fluid-filled cavity in the brain (ventricle), if the surgeon, lead investigator, and study sponsor determine this creates a risk related to the drug delivery procedure.
• For the Phase 2 part of the trial only: people whose tumour volume is greater than 20 cm³ are not eligible for that phase of the study.

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