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:

General criteria that apply to all groups:

• People aged 18 or older.
• People whose cancer is not located only in the lower back part of the brain (posterior fossa) or only within the spinal cord itself.
• People who have recovered from most side effects of previous cancer treatments, with side effects having settled to mild levels or back to their normal baseline (hair loss and mild nerve-related symptoms are exceptions).
• People who are medically able and willing to have a small device called an Ommaya reservoir placed under the scalp (used to deliver treatment directly to the fluid around the brain).
• People whose steroid dose (such as dexamethasone) is expected to be low — no more than 4 mg per day — at the time of the first treatment infusion.
• People with a performance score of 60% or higher on the Karnofsky scale, meaning they are able to carry out some daily activities with some assistance (confirm with trial site).
• People who are able to have an MRI scan with contrast dye.
• People with a life expectancy of more than 3 months.
• People whose blood counts, liver function, and kidney function meet the required levels as assessed by standard blood tests (confirm specific values with trial site).
• People with no prior cancer history, OR who have been cancer-free for 5 or more years, OR who have only had certain non-invasive skin or early-stage cancers (such as basal cell or squamous cell skin cancer, early cervical, breast, or prostate cancer).
• People whose heart is pumping effectively, with a left ventricular ejection fraction above 50% as confirmed by a heart ultrasound.
• People who are willing and able to use adequate contraception during the study and for 4 months after treatment ends. Women who become pregnant or suspect pregnancy during the study must inform their treating doctor immediately.
• People who are able to understand and sign a written consent form.

Group-specific criteria:

• Safety Run-In and Arm 1 (returning GBM with EGFRvIII mutation): People with a confirmed diagnosis of returning (recurrent) glioblastoma (GBM) that carries a specific genetic change called EGFRvIII, whose cancer is coming back for the first time and who are planning to have a biopsy or surgery. People must have previously received radiation therapy. Prior chemotherapy with temozolomide may not be required in certain cases (confirm with trial site). People must have waited at least 2 weeks since certain prior treatments, and have a visible tumour of at least 1 cm on MRI.
• Arm 2 (newly diagnosed GBM with EGFRvIII mutation — opens only after safety is confirmed in other arms): People newly diagnosed with GBM carrying the EGFRvIII mutation, whose tumour has a specific genetic feature called MGMT unmethylated, and whose treatment plan includes radiation to the affected area only, without chemotherapy. People in this group must have completed at least 75% of the planned 6-week radiation course before receiving the trial treatment, and must not have had any prior cancer-directed treatment other than radiation.
• Arm 3 (returning GBM without EGFRvIII mutation): People with confirmed returning GBM that shows EGFR amplification but does not carry the EGFRvIII mutation, whose cancer is returning for the first time and who are planning a biopsy or surgery. Prior radiation is required, and the same waiting periods from prior treatments apply as in Arm 1. A visible tumour of at least 1 cm on MRI is required.
• Arms 1 and 3: People must be at least 3 months past completing radiation, unless there is evidence that the cancer has grown outside the area that received the highest radiation dose.

Who may not be able to join:

• People whose GBM is located only in the lower back part of the brain (posterior fossa) or only within the spinal cord.
• People who have previously received treatments specifically targeting the EGFRvIII mutation.
• People who have previously been treated with bevacizumab (a specific anti-cancer drug).
• People who have previously received any gene therapy or cell therapy involving genetic modification.
• People who have or need a VP shunt (a device that drains fluid from the brain).
• People who are currently taking ongoing immunosuppressant medications (such as cyclosporine or high-dose steroids). Occasional use of topical, inhaled, or nasal corticosteroids is allowed.
• People who still have significant side effects (above mild levels) from previous cancer treatments, except for hair loss.
• People currently taking part in another clinical trial involving an experimental treatment.
• People with a known history of serious allergic reactions to drugs with a similar composition to the trial treatment, such as cetuximab.
• People with other serious uncontrolled medical conditions.
• People living with HIV.
• People with chronic hepatitis B infection or active hepatitis C infection.
• People with psychiatric or personal circumstances that would make it difficult to follow the study requirements.
• Women who are pregnant or breastfeeding.

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