Phase 1 Lymphoma 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 a recurrent brain tumour (malignant glioma) with a specific genetic mutation called IDH-mutant, graded as WHO grade 3 or 4, that has shown signs of growing again on scans and is suspected to have returned as active tumour — including people originally diagnosed with a lower-grade (WHO grade 2) IDH-mutant tumour that has now developed higher-grade features.
• People whose recurrent IDH-mutant malignant glioma has come back after receiving standard treatments.
• People who have had an MRI scan within the past 30 days showing a tumour that is enhancing on scan, is less than 32 cc in total size, does not cause severe pressure in the brain, and is located in a position that can be safely reached by a surgical needle (stereotactic biopsy).
• People with a functional ability score (Karnofsky score) of 70 or above, meaning they are able to care for themselves and carry out some normal activity.
• People who are willing and able to use birth control: women of childbearing potential must use contraception for at least 1 month after chemotherapy, and men must use contraception for at least 4 months after chemotherapy ends.
• People (or their legal representatives) who are able to give informed consent to participate in the trial.
• People who are willing and medically fit enough to undergo the surgical procedure involved in the trial.
• People aged 18 years or older.
• People whose blood and organ function tests, taken within 14 days before joining, show results within acceptable ranges — including adequate white blood cell counts, platelet levels, liver function, and kidney function.

Who may not be able to join:

• People whose tumour has spread widely along the inner lining of the brain cavities or into the fluid surrounding the brain and spinal cord.
• People whose tumour involves the cerebellum (the lower back part of the brain) or affects both sides of the brain.
• People who currently have an active infection being treated, or who have an unexplained fever.
• People who are known to be HIV-positive, or positive for Hepatitis B or Hepatitis C.
• People who have other serious medical conditions that would make surgery or anaesthesia unsafe.
• People who have previously received topotecan (the chemotherapy drug used in this trial) as a systemic (whole-body) treatment for their tumour.
• People who are unable to have MRI or PET scans.
• People who have had an allergic reaction to topotecan, similar chemotherapy drugs (topoisomerase inhibitors), or gadolinium contrast agents used in MRI scans.
• People currently taking certain medications that interact with topotecan in ways that could affect how the drug works or cause harm — including specific drugs processed by liver enzymes (CYP3A4/5 or CYP2C8) or drugs that affect heart rhythm (confirm with trial site); people on such medications may need to stop them at least two weeks before the trial treatment begins.
• People with other serious uncontrolled medical conditions, such as active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• Women of childbearing potential who do not have a negative pregnancy test result within 7 days of joining the trial.
• Women who are currently breastfeeding.

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