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 recurrent glioblastoma (or a related brain tumour type called gliosarcoma), confirmed by MRI scan, biopsy, or advanced imaging such as PET or special MRI techniques.
• People whose diagnosis of glioblastoma or gliosarcoma meets the 2021 World Health Organization (WHO) classification — including cases where older pathology reports have been reviewed and reclassified under current standards.
• People whose returning tumour, as seen on MRI, measures no more than 6 cm at its longest point across all areas of likely tumour combined.
• People who previously received standard brain radiation therapy at a conventional dose range (1.8–2 Gy per treatment session, up to a maximum total of 63 Gy).
• People who finished their prior brain radiation at least 4 to 6 months before starting this study, depending on where the tumour has returned in relation to the original radiation area (confirm with trial site for the specific timeframe that applies).
• People who have waited a required amount of time since their last anti-tumour or experimental treatment — generally at least 28 days, or 5 half-lives of the drug (whichever is shorter), though shorter waiting periods apply for some specific chemotherapy drugs (confirm with trial site).
• People aged 18 or older.
• People who are able to have MRI scans.
• People who are able to give written informed consent.
• People with a general physical functioning level rated 0–2 on the ECOG scale, meaning they are fully active, have some limits on strenuous activity, or are up and about more than half of waking hours (confirm with trial site).
• People whose treating doctor estimates they have a life expectancy of more than 12 weeks.
• People who are female and either have a negative pregnancy blood test, or have confirmed menopause, or have had a hysterectomy and/or removal of the ovaries.
• People of childbearing potential (both male and female) who agree to use effective contraception throughout treatment and for at least 6 months after the last treatment, as the medications used may be harmful to an unborn baby.
• People with recent blood test results (within the past 21 days) showing adequate blood cell counts: white blood cell count of at least 1,500 cells/mm², platelet count of at least 75,000 cells/mm², and haemoglobin of at least 9.0 g/dL (a transfusion to reach this level is acceptable).
• People with recent liver function blood test results (within the past 21 days) showing total bilirubin at or below 2 mg/dL and liver enzyme levels (AST/SGOT) no more than 2.5 times the upper limit of normal.
• People with recent kidney function results (within the past 21 days) showing a creatinine level at or below 1.8 mg/dL, and urine protein levels within acceptable ranges as determined by specific urine tests conducted within 14 days before registration (confirm exact requirements with trial site).
• People taking full-dose blood thinners, provided they have no active or high-risk bleeding and their blood thinning levels are stable and within the target range on recent testing (within 21 days before registration).

Who may not be able to join:

• People with a brain tumour other than glioblastoma or gliosarcoma as defined by WHO 2021 criteria (note: benign tumours such as meningioma are permitted).
• People whose glioma has not yet been treated with a first course of standard radiation therapy.
• People who have already undergone a second course of radiation therapy for their glioma.
• People whose tumour has spread to separate areas across multiple different lobes of the brain (note: multiple nodules within the same region are allowed if the total size is 6 cm or less).
• People who have previously received the drug Bevacizumab as part of their treatment.
• People who will receive any chemotherapy at the same time as the study treatment, other than Bevacizumab.
• People whose returning tumour is located in specific brain regions known to cause problems with the MRI scans used in this study, including certain parts of the temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum (confirm with trial site).
• People who are pregnant or breastfeeding.
• People with a history of another invasive cancer (other than certain non-melanoma skin cancers) unless they have been cancer-free for at least 1 year (non-invasive cancers such as carcinoma in situ are generally permitted).
• People with serious active health conditions, including: unstable angina or heart failure requiring hospitalisation in the past 6 months; a heart attack in the past 6 months; a stroke or mini-stroke (TIA) in the past 6 months; significant blood vessel disease such as aortic aneurysm; a current serious bacterial or fungal infection requiring intravenous antibiotics; a current severe lung condition requiring hospitalisation; liver failure causing jaundice or clotting problems; or a diagnosis of AIDS as defined by current CDC criteria (HIV testing is not required to apply).
• People who are unwilling or unable to use medically acceptable contraception, as the treatment may cause serious harm to an unborn baby.
• People who have had a previous allergic reaction to Bevacizumab.
• People with a prior history of a hypertensive crisis or hypertensive encephalopathy (a severe and dangerous rise in blood pressure affecting the brain).
• People with a wound, ulcer, or bone fracture that has not healed within the past 90 days.
• People who have experienced a significant gastrointestinal bleed or other major bleeding event (rated Grade 3 or higher) within the past 30 days.
• People who have had a major surgery, open biopsy, or significant traumatic injury within the past 28 days (craniotomy brain surgery is an exception to this rule).
• People who are currently taking part in another clinical trial involving an investigational treatment.

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