Phase 1 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 (confirmed by tissue analysis) with a returning (recurrent) high-grade brain tumour (WHO grade 3 or 4 malignant glioma) located in the upper part of the brain (supratentorial region), including tumours with molecular features of glioblastoma.
• For one specific group (Subgroup #3), the treating brain surgeon must determine that a device called the Tumor Monorail Device (TMD) can be safely implanted.
• People aged 18 or older at the time of joining the trial.
• People who are either not able to become pregnant (due to menopause, surgery, or not being sexually active), or who agree to use an approved method of birth control (such as hormonal contraception, an intrauterine device, or a barrier method with spermicide) — this applies to the patient and/or their partner(s).
• People with a general health and functioning score (Karnofsky Performance Score) of 70% or above, meaning they are able to care for themselves and carry out some normal activity.
• People whose blood test results before the biopsy meet all of the following levels: haemoglobin at least 9 g/dL; platelets at least 100,000/µL (and at least 125,000/µL at the time of the procedure, which may be reached with a platelet transfusion); neutrophil count at least 1,000; creatinine no more than 1.5 times the normal upper limit; total bilirubin no more than 1.5 times the normal upper limit (or up to 3 times if Gilbert's Syndrome is confirmed); liver enzymes (AST/ALT) no more than 2.5 times the normal upper limit; and blood clotting times (prothrombin and partial thromboplastin) no more than 1.2 times normal.
• People who have previously had a blood clot may still be considered, provided blood-thinning medication is paused around the time of surgery as directed by the surgical team, and if on warfarin, the INR must be below 2.0 before the biopsy.
• People whose returning tumour is confirmed by tissue analysis at the time of the biopsy, before the study treatment is given.
• People who are able to read, understand, and sign the official consent form approved by the ethics review board.
• People who are able to have a brain MRI scan with and without contrast dye.
• People who have completed all standard treatments, including surgery and radiation therapy, before joining (confirm with trial site for specific radiation dose requirements based on age and tumour characteristics).
• People whose tumour has a specific genetic marker called MGMT that is unmethylated are not required to have had chemotherapy before joining.
• People whose tumour has a methylated MGMT marker, or whose MGMT status is not yet known, must have received at least one course of chemotherapy before joining.

Who may not be able to join:

• People who are pregnant or currently breastfeeding or chestfeeding.
• People whose condition involves a life-threatening brain pressure emergency (cerebral herniation syndrome), as assessed by the study surgeons.
• People with a serious active infection requiring intravenous antibiotics, or an unexplained fever above 99.5°F (37.5°C).
• People with a known disease that weakens the immune system, or a known HIV infection.
• People with unstable or severe medical conditions, such as serious heart disease (classified as New York Heart Association Class 3 or 4).
• People with significant known lung disease (where lung function is below 50% of expected) or uncontrolled diabetes.
• People with a known allergy to albumin (a protein used in the treatment).
• People who have received chemotherapy or bevacizumab within 4 weeks before starting the study drug, unless they have fully recovered from side effects — different waiting periods apply for certain chemotherapy types (confirm with trial site).
• People who have received immunotherapy within 4 weeks before starting the study drug, unless side effects have fully resolved.
• People who have received tumour treating fields therapy (such as Optune) within 1 week before starting the study drug.
• People who are less than 12 weeks out from radiation therapy, unless specific conditions are met such as confirmed tumour growth outside the treated area or two scans showing progression at least 4 weeks apart, or tissue confirmation of recurrence.
• People whose tumour is located in the brainstem, cerebellum, or spinal cord; or who have evidence of actively growing tumour in multiple locations; or extensive tumour spread along the inner lining of the brain cavities; or tumour crossing the midline of the brain; or tumour spread to the membranes surrounding the brain or spinal cord.
• People taking more than 4 mg per day of the steroid dexamethasone within the 2 weeks before the study treatment infusion.
• People experiencing progressive muscle weakness in both arms and legs due to steroid use (steroid myopathy).
• People currently being treated for a separate, unrelated cancer — with the exception of certain low-risk skin cancers or cervical carcinoma in situ.
• People with an active autoimmune disease that has required systemic immune-modifying treatment within the past 3 months.
• People in Subgroup #3 (the TMD device group) who have a known allergy to silicone, polyurethane, or titanium, which are materials used in the device.

Salvage Treatment (an additional treatment option available only to certain patients treated under an earlier version of this trial — confirm eligibility with the trial site):

Who might be able to join this part:

• People whose tumour (WHO grade 4 malignant glioma in the upper brain) has returned based on imaging, and who need further treatment beyond what is already permitted under the trial.
• People who are at least 4 months past their original study treatment (intratumoral administration of D2C7-IT + 2141-V11).
• People who are able to sign a new consent form specifically for this salvage treatment.
• People who meet appropriate birth control or non-childbearing requirements, as described above (including a negative pregnancy blood test at screening for those who could potentially become pregnant).
• People whose pre-treatment blood results meet the following levels: total bilirubin no more than 1.5 times the normal upper limit (or up to 3 times if Gilbert's Syndrome is confirmed); liver enzymes (AST/ALT) no more than 2.5 times normal; neutrophil count at least 1,000; platelets at least 50,000/µL; creatinine no more than 1.2 times the normal upper limit.

Who may not be able to join this part:

• People who are pregnant or breastfeeding or chestfeeding.
• People with a serious active infection requiring intravenous treatment, or an unexplained fever above 99.5°F (37.5°C).
• People with a known immune-weakening disease or HIV infection.
• People with unstable or severe heart disease (New York Heart Association Class 3 or 4).
• People with significant known lung disease (lung function below 50% of expected) or uncontrolled diabetes.
• People with a general health and functioning score (Karnofsky Performance Score) below 60%.
• People taking more than 4 mg per day of dexamethasone within the 2 weeks before the salvage treatment injection.
• People with an active autoimmune disease requiring systemic immune-modifying treatment within the past 3 months.

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