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 with glioblastoma (a type of brain tumour), confirmed by a pathology report using the 2021 World Health Organization classification.
• People whose brain scans show that the tumour has grown or returned after previous treatment.
• People who have recently had surgery to remove a returning or growing tumour, as long as they have recovered from that surgery — measurable disease on scans after surgery is not required.
• People who have previously received standard radiation treatment for glioblastoma (including shorter courses of 40 Gy, standard courses of 60 Gy, or proton therapy).
• People who have fully recovered from the side effects of their previous treatments.
• People whose previous treatments have been stopped for the required time periods before joining — for example, at least 4 weeks since chemotherapy drugs such as temozolomide, or at least 12 weeks since radiation therapy (or 4 weeks if a new tumour area has appeared outside the original radiation zone) (confirm with trial site for specific timings).
• People whose recent blood test results (taken within 14 days before joining) show that their bone marrow, liver, and kidneys are functioning at an adequate level (confirm with trial site for specific values).
• People who have a performance status score of 50 or above on the Karnofsky scale, meaning they are able to carry out some self-care but may need some assistance with daily activities (confirm with trial site).
• People who are willing and able to use effective contraception during the trial and for up to 3.5 months after the last treatment, or who have been surgically sterilised — this applies to people who could become pregnant or whose partners could become pregnant.
• People who are currently taking blood thinners (such as warfarin or low molecular-weight heparin) at a stable dose, or common pain and anti-inflammatory medicines such as aspirin or ibuprofen.
• People who are willing to avoid other glioblastoma treatments while taking part in the trial.
• People who are able to swallow oral (by mouth) medication.
• People aged 18 or older at the time of providing consent.
• People who are able to understand the trial information and are willing to sign a consent form.
• People who are willing and able to attend required visits, follow study procedures, and have regular blood samples taken.

Who may not be able to join:

• People who are not considered suitable candidates for a stereotactic biopsy (a type of guided needle biopsy of the brain) or laser ablation procedure.
• People who have previously been treated with a group of chemotherapy drugs called nitrosoureas, such as lomustine, carmustine, or nimustine.
• People who have previously been treated with carmustine wafers (a type of chemotherapy implanted during brain surgery).
• People who have previously been treated with bevacizumab (a targeted therapy drug).
• People who have received an experimental treatment within 4 weeks, or within 5 drug half-lives (whichever is the shorter period), before starting the trial.
• People whose baseline brain MRI shows signs of recent bleeding in the brain — with some exceptions, such as small or resolving bleeds related to surgery or the tumour itself (confirm with trial site).
• People who have had a brain abscess (infection) within the 6 months before starting the trial.
• People who have had major surgery, an open biopsy, or a serious injury within 28 days before starting the trial, or who are expected to need major surgery during the trial.
• People with a serious wound, ulcer, or bone fracture that has not been healing.
• People who are pregnant or breastfeeding.
• People who have a known allergy to lomustine or any of its ingredients.
• People with serious ongoing or uncontrolled illness, such as an active infection, uncontrolled high blood pressure, or a significant heart rhythm problem that requires medication and could affect safety or participation in the trial.
• People who are unable to have an MRI scan with contrast dye.
• People with a known allergy to nitrosourea drugs (such as lomustine, carmustine, or nimustine).
• People who, in the opinion of the trial doctor, have any other condition that could affect their safety or ability to take part in the trial.

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