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 given written consent showing they understand the study and agree to follow its requirements
• People aged between 18 and 80 years old
• People who are reasonably functional in daily life, as measured by a standard medical scale (WHO performance status of 2 or below)
• People who have been newly diagnosed with glioblastoma (a type of brain tumour), confirmed by tissue testing under the 2021 WHO guidelines, and whose tumour does not have a specific gene change called an IDH mutation
• People whose glioblastoma has not progressed after surgery and initial treatment with radiation plus chemotherapy — and who had a surgical tumour removal (not just a biopsy)
• People who have completed a full course of radiation therapy (at least 90% of the planned dose) combined with a chemotherapy called temozolomide (at least 66% of planned doses)
• People whose side effects from chemoradiation have settled back to their pre-treatment level, or are mild (Grade 2 or lower), apart from hair loss or low white blood cell counts
• People whose blood counts, liver function, kidney function, and blood clotting results meet the required levels as determined by laboratory tests
• Women who are not pregnant or breastfeeding, and who are either post-menopausal, have had certain sterilisation procedures, or agree to use effective contraception during the study and for 30 days after the last treatment (confirm with trial site for specific contraception requirements)
• Women of childbearing potential who have a negative pregnancy blood test within 7 days before the first study drug is given
• Male participants who are either surgically sterile (at least 3 months after a vasectomy) or who agree to use a highly effective double-barrier contraception method during the study and for at least 30 days after treatment, and who agree not to donate sperm during this period
• People who have not received any additional cancer treatment after completing radiation, other than temozolomide chemotherapy taken for 5 days as directed by the approved prescribing information

Who may not be able to join:

• People whose tumour is located in the lower back part of the brain (cerebellum) or brainstem
• People whose tumour affects both sides of the brain, crosses a structure called the corpus callosum on both sides, or involves the brainstem or cerebellum as seen on a specialised brain scan (MRI with contrast)
• People with tumour in multiple separate locations in the brain (confirm with trial site for exact definition)
• People whose tumour has spread to the lining of the brain or spinal cord (leptomeningeal disease)
• People whose tumour has been identified as a specific type called gliosarcoma
• People who plan to use a device called Tumour Treating Fields (TTF) at any point during the study (prior use before screening is acceptable)
• People taking more than 4 mg per day of the steroid dexamethasone (or an equivalent steroid dose), or whose steroid dose has not been stable or decreasing for at least one week before joining
• People who are unable to have an MRI scan or receive a contrast dye called gadolinium
• People who have a known allergy or sensitivity to the study drug 5-ALA or to substances called porphyrins
• People whose head measurements are too large to fit the specialised helmet device used in the trial
• People who have certain skull defects or gaps above a specified size (confirm with trial site for details)
• People who have had a stroke or bleeding in the brain in the past 6 months, not related to their brain tumour surgery
• People who have a history of any other glioma, a current cancer, or another cancer diagnosed within the past 3 years — unless treatment for that cancer is fully completed (certain minor skin cancers or early-stage cancers that have been successfully treated may still be eligible — confirm with trial site)
• People experiencing significant brain swelling that needs urgent medical treatment
• People whose condition is rapidly getting worse in a way the treating doctor expects to continue during the first treatment cycle
• People who have received any prior treatment for glioma other than surgical removal and chemoradiation with temozolomide — this includes but is not limited to stereotactic radiosurgery, certain chemotherapy wafers placed during surgery, other chemotherapy drugs, bevacizumab, immunotherapy, or other experimental treatments (TTF used before the study is acceptable)
• People with an active form of a blood disorder called porphyria (acute or chronic)
• People with a digestive condition that affects how the body absorbs medications
• People with a known active hepatitis B or C infection
• People with a known HIV infection
• People currently enrolled in another interventional clinical trial for glioblastoma (observational studies are permitted)
• People who are unable to avoid certain medications that increase sensitivity to light (such as St. John's Wort and certain antibiotics or diuretics — confirm with trial site for the full list) for 24 hours before and after receiving 5-ALA
• People with another serious or poorly controlled medical condition that could affect safe participation in the study, such as significant heart, lung, psychiatric, or neurological conditions, or an active uncontrolled infection
• Women who are pregnant or breastfeeding
• People who, in the opinion of the treating doctor, would be unable to give proper consent, follow study instructions, or whose participation might make the results difficult to interpret or place them at undue risk

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