Phase 2 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 are male or female and older than 18 years of age at the time of signing consent
• People who have breast cancer that has spread to the brain (in the upper and/or lower parts of the brain) and is continuing to grow, with at least one affected area that has not yet been treated with radiation and measures 2 cm or smaller in a non-sensitive part of the brain (as determined by the treating specialist)
• People who have at least one brain metastasis site that has not previously been treated with radiation
• People who have a specific virus called cytomegalovirus (CMV) detected in their blood through a particular test, or who test positive for CMV antibodies (confirm with trial site)
• People who are able to give written consent themselves, or who have a legally authorised guardian who can do so on their behalf
• People with metastatic breast cancer whose cancer outside the brain may be in any state — fully gone, partially responding to treatment, stable, or still growing
• People whose general health and ability to carry out daily activities falls within a certain range on a standard medical scale (a score of 0 to 2 on the ECOG scale, meaning from fully active to capable of self-care but unable to do physically demanding work) (confirm with trial site)
• People whose blood counts are at acceptable levels without needing ongoing blood transfusions (specific thresholds apply — confirm with trial site)
• People whose kidney and liver are functioning at adequate levels (specific thresholds apply — confirm with trial site)
• People who may be receiving other CMV treatment if their doctor has determined it is clinically needed
• Women who are post-menopausal (as defined by specific criteria related to age, hormone levels, absence of periods, or surgical history) or who have a negative pregnancy blood test within 7 days before the first dose of the study treatment
• People who are willing and able to attend all required visits, treatments, and follow-up appointments for the full duration of the study

Who may not be able to join:

• People who have only one brain lesion that could be surgically removed
• People whose brain metastases have not progressed for more than 12 months since the last progression
• People whose brain metastases have all already been treated with radiation
• People whose brain metastases require immediate treatment due to serious complications such as pressure on the brain, brain shifting, active neurological symptoms, or lesions very close to critical brain structures — unless there are other untreated brain metastases present (a specialist team review will determine whether safe enrolment is possible)
• People who are currently pregnant or breastfeeding
• Women who could become pregnant, or men who could father a child, who are unwilling to use effective contraception during the study and for up to three months after treatment ends
• People with a known psychiatric condition that would make it difficult to follow the trial requirements
• People who have had another cancer in the past, unless they have been free of that cancer for at least 3 years — exceptions may apply for certain non-serious skin cancers or early-stage cervical conditions (confirm with trial site)
• People who have participated in another clinical trial involving an experimental treatment within the 28 days before the first dose of the study treatment
• People who are currently enrolled in another interventional clinical trial (participation in a non-interventional observational study or being in a follow-up phase of a previous trial may be acceptable — confirm with trial site)
• People who still have unresolved or unstable side effects from a previous experimental treatment, as determined by the investigator
• People who have had a major surgical procedure within 28 days before the first dose of the study treatment
• People who do not speak English, as the memory and thinking tests used in this trial have only been validated in English

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