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:

• The patient (or their parent or legal guardian, if applicable) must agree to participate in writing, and younger patients must also provide written agreement where required by their age and country.
• People with a brain tumor diagnosis — specifically high-grade glioma, medulloblastoma, ATRT, EMTR, pineoblastoma, or ependymoma — that has come back or stopped responding to treatment, where complete surgical removal is not possible, and where life expectancy is at least 16 weeks at the time of joining.
• Tumor recurrence within a previously treated radiation area may be considered if the tumor has shown confirmed growth on two separate MRI scans, if it appeared at least 12 weeks after radiation was completed, or if a tissue sample has confirmed the tumor has returned.
• People aged 1 to 25 years (male or female).
• People with a single measurable tumor larger than 10 mm across in two directions, which the medical team considers safely reachable for a biopsy and injection procedure.
• People who meet a minimum functional ability score — assessed using age-appropriate medical scales — indicating they are reasonably able to carry out daily activities (confirm with trial site for exact thresholds).
• People who have not received chemotherapy or immunotherapy in the 4 weeks before joining the trial.
• People who are either not taking corticosteroids (a type of anti-inflammatory medication), or whose dose has been stable or decreasing for at least 2 weeks before the study treatment is given.
• People who have not received any form of radiation therapy in the 6 weeks before joining the trial.
• People who have had a stem cell transplant must be at least 3 months past that transplant before joining.
• People who have fully recovered from any side effects of previous treatments.
• People whose blood counts, kidney function, and liver function fall within acceptable ranges on laboratory tests (confirm with trial site for exact values).
• Female participants who could potentially become pregnant must have a negative pregnancy test before joining.
• Sexually active female participants who could become pregnant must agree to use an accepted form of contraception from the time of consent until at least 120 days after receiving the study treatment; male participants must agree to use contraception from consent until at least 90 days after treatment.

Who may not be able to join:

• People with a medical or psychological condition that could affect their ability to take part or, for those aged 16 and over, to give informed consent.
• People whose tumor is located in the spine, or whose tumor location is considered too risky for the injection procedure, or where the virus could potentially enter the fluid-filled spaces of the brain.
• People who have received treatments that fall outside the guidelines described in the eligibility criteria above.
• People with a severe active infection or a serious medical condition affecting the kidneys, liver, heart, or bone marrow that the medical team considers would make participation unsafe.
• People with immune system deficiencies, autoimmune conditions, active hepatitis, or known HIV infection.
• People who have another separate primary cancer diagnosis.
• People with a prior history of brain inflammation (encephalitis), multiple sclerosis, other brain or nervous system infections, or other brain conditions that could affect how results are assessed.
• People with Li-Fraumeni Syndrome or a known inherited fault in the retinoblastoma gene or related genetic pathways.
• People currently taking antiviral medications or immune-suppressing medications (other than steroids).
• People who have received a live or weakened live vaccine within 30 days before the study treatment, or who would need such a vaccine during the trial (non-live vaccines are permitted).
• People who have previously taken part in an experimental viral therapy study.
• People who are unable to have MRI scans for any reason.
• People who are pregnant or breastfeeding.

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