Phase 2 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:

• You have been diagnosed with a specific type of brain tumor (anaplastic astrocytoma or glioblastoma multiforme), confirmed by a biopsy taken during surgery, that has not spread to multiple separate areas of the brain or into the brainstem.
• Your doctor expects you to live for at least 12 weeks.
• You are either newly diagnosed with this brain tumor, or you have had previous surgery for it but have not yet received radiation therapy or chemotherapy.
• You are generally able to carry out normal daily activities with little or no limitation (confirm with trial site regarding the specific activity scale used).
• You do not have any other active cancers, except for certain common skin cancers (squamous or basal cell).
• You are willing to have biopsies taken as required by the study.
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 7 days before starting treatment and you are not breastfeeding.
• You and/or your partner are willing to use an effective form of birth control during the study.
• Your kidneys, liver, and blood counts are within acceptable ranges based on recent blood tests.
• You have given your written agreement to take part after being fully informed about the study.
• Patients with cancer that has spread to the lining around the brain and spinal cord (leptomeningeal disease) may also be considered (confirm with trial site).

Who may not be able to join:

• You have received immunotherapy, immune-modifying therapy, or gene therapy within the past 3 months.
• You have received chemotherapy, radiation, immunotherapy, or any experimental drug within 3 weeks of starting the study.
• Your brain tumor has spread to multiple separate areas (lesions larger than 2 cm apart from the main tumor site) or involves the brainstem.
• You are currently taking immune-suppressing medications, other than steroids used to reduce brain swelling.
• If you have leptomeningeal disease, there is evidence it has spread widely or into the spine, or there are large deposits that could block the flow of fluid around the brain and spinal cord.
• You have liver disease such as cirrhosis, or active or chronic hepatitis B or C.
• You have had problems with alcohol misuse or abuse within the past 12 months.
• You have a known allergy or sensitivity to any part of the study treatment, including the gene therapy component or the medication Valacyclovir.
• You are unable to swallow or have a condition affecting your upper digestive tract that prevents you from taking oral medication (Valacyclovir is taken by mouth).
• You have another active cancer, unless it is a non-melanoma skin cancer, early-stage cervical cancer, or a previously treated cancer from which you have been completely free for more than 3 years.
• You have an active brain infection called toxoplasmosis or a condition called Progressive Multifocal Leukoencephalopathy, seen on a brain scan.
• You have an active, untreated skin infection (cellulitis) or untreated wound infection.
• You are actively misusing intravenous drugs or have severe opioid misuse issues.
• You are pregnant or breastfeeding, or you are able to have children and are unwilling to use effective birth control.
• You have an active or uncontrolled infection, a weakened immune system, or a positive HIV test result.
• You are under 18 years of age.
• You are unwilling or unable to follow the study's requirements and schedule.

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