Phase 3 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 newly diagnosed with a brain tumour (called a CNS glioma, grade 2 or 3), confirmed by laboratory testing of tumour tissue.
• People whose tumour has a specific genetic change called an IDH mutation, identified through laboratory testing.
• People whose tumour has a specific chromosomal change called 1p/19q co-deletion, identified through laboratory testing.
• People who have had a biopsy or surgical removal of the tumour, with enough tissue collected for molecular testing.
• People aged 18 or older.
• People who have a general health and functioning score of at least 60% on the Karnofsky Performance Scale (a measure used by doctors to assess how well a person can carry out daily activities).
• People with a life expectancy of more than 6 months.
• People for whom tumour tissue samples and a blood sample are available for research purposes.
• People who have had a standard brain MRI scan within 72 hours after surgery, in line with current guidelines.
• People whose surgical site (from brain surgery or biopsy) has healed adequately.
• People who are at least 2 weeks but no more than 3 months past their surgery, and who have not received any chemotherapy, radiotherapy, or experimental treatment in the meantime.
• People who are willing and able to take part in regular brain function and quality-of-life tests and questionnaires.
• People for whom post-surgical drug treatment has been recommended by their medical team.
• People who have provided written informed consent to participate.
• Women of reproductive potential who have a negative pregnancy test at the required screening timepoints, and who are either surgically sterile, post-menopausal for at least 2 years, or agree to use adequate contraception during treatment and for 7 months after treatment ends.
• Men who are willing to use contraception during the trial.

Who may not be able to join:

• People who are currently taking part in another interventional clinical trial.
• People who are unable to have an MRI scan.
• People with abnormal blood test results at a certain severity level, including problems with blood cell counts, liver function, or kidney function (confirm with trial site for specific thresholds).
• People with clinically active tuberculosis, known HIV infection, active Hepatitis B or C, active infections requiring antibiotic treatment, or certain other serious infections.
• People who have previously received anti-cancer treatment, except for people with a history of low-grade glioma that did not require prior chemotherapy or radiotherapy.
• People who have a weakened immune system unrelated to prior cancer treatment.
• People who have had another cancer within the last 5 years, unless they have been free of that cancer for 5 years (certain minor skin cancers may be exceptions — confirm with trial site).
• People with a significant other medical condition, including hereditary fructose intolerance, that could interfere with the trial or pose unacceptable risk (as determined by the treating doctor).
• People with psychological, family, social, or geographical circumstances that could make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding.
• People with a known allergy or hypersensitivity to the study drugs or their ingredients.
• People with a certain type of heart rhythm abnormality (QTc interval greater than 500 ms on an ECG).
• People for whom any of the study drugs (procarbazine, lomustine, vincristine, or temozolomide) are restricted or contraindicated.
• People with significant liver disease, including seriously elevated liver enzymes, impaired liver function, or active hepatitis (viral, autoimmune, alcohol-related, or other types).
• People with an uncorrected blood clotting disorder, platelet disorder, or a history of low platelet counts not caused by medication.
• People with a history of most autoimmune diseases (such as lupus, rheumatoid arthritis, multiple sclerosis, or others listed in the trial criteria). Note: People with autoimmune-related thyroid conditions on a stable thyroid hormone dose, or Type 1 diabetes on a stable insulin regimen, may still be considered eligible — confirm with trial site.
• People who have received a live vaccine within 4 weeks before starting treatment, or who would need one during treatment.
• People with existing neuromuscular diseases, particularly a condition called Charcot-Marie-Tooth syndrome (demyelinating form).
• People with chronic constipation or a partial bowel blockage (subileus).
• People who are being treated with a drug called mitomycin.
• People with a known allergy to a drug called dacarbazine (DTIC).
• People with hereditary galactose intolerance, complete lactase deficiency, or glucose-galactose malabsorption (one of the study drugs, Temodal, contains lactose).
• People with a clinical wheat allergy.

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