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:

Before radiation treatment starts (Step 1):

• Adults aged 18 or older who have agreed to take part by signing a consent form
• People who have been newly diagnosed with a specific type of brain tumour called glioblastoma, confirmed by laboratory testing to have certain genetic features: EGFR amplification, no MGMT methylation, and IDH wildtype status, with tumour tissue showing specific features under a microscope
• People who have had surgery to remove as much of the tumour as safely possible (a biopsy alone is not enough)
• People whose tumour tissue has been confirmed EGFR-amplified by a specific laboratory (Neogenomics Laboratories)
• People with a Karnofsky Performance Status score of 60% or higher, which is a medical measure of general physical functioning (confirm with trial site)
• People whose treatment plan includes 60 Gy of radiation therapy, using either standard or proton radiation

Before the main treatment phase starts (Step 2):

• People who have completed the full 60 Gy course of radiation therapy
• People whose scans show no clear signs of the tumour returning or growing after radiation, based on a standard assessment system called RANO 2.0
• People with a Karnofsky Performance Status score of 60% or higher at this stage
• People whose kidneys, liver, and heart are functioning well enough, based on blood test results and heart scans, and whose blood oxygen level on room air is above 92%

Who may not be able to join:

Before radiation treatment starts (Step 1):

• People with an active hepatitis B or hepatitis C infection
• People with significant heart problems classified as Class III or IV by a standard heart health scale
• People whose tumour involves certain deep brain or spinal areas, including the thalamus, brain stem, or spinal cord
• People whose tumour MGMT testing shows any level of methylation, or where the result was unclear
• People with tumour that has spread to more than one area in the brain, where not all areas have had maximal safe surgery
• People with serious ongoing health conditions that, in the treating doctor's opinion, would make participation unsafe
• People with a known allergy or sensitivity to any of the study product ingredients, specifically human serum albumin, DMSO, or Dextran 40
• People with an active autoimmune disease requiring immune-suppressing medication at or above a certain dose (equivalent to 10mg or more of prednisone daily), or people with autoimmune neurological conditions such as multiple sclerosis
• People whose planned treatment includes a drug called bevacizumab, any other cancer-fighting systemic therapy, or tumour-treating fields as part of their first-line treatment

Before the main treatment phase starts (Step 2):

• People with any active, uncontrolled infection at this stage
• People with serious ongoing health conditions that, in the treating doctor's opinion, would make continued participation unsafe
• People who have experienced significant physical or neurological decline that, in the treating doctor's opinion, would make continued participation unsafe
• People who are pregnant or breastfeeding; people who could become pregnant must agree to use an acceptable form of contraception
• People who have already received bevacizumab or temozolomide as treatment for their glioblastoma
• People whose planned post-radiation treatment includes tumour-treating fields, bevacizumab, or any other cancer-fighting therapies
• People already enrolled in another clinical trial for their glioblastoma

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