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:

• People who have a confirmed diagnosis (proven by biopsy) of recurring anaplastic astrocytoma or glioblastoma multiforme, without the tumour appearing in multiple separate areas of the brain or in the brainstem.
• People whose brain scans show signs that the tumour has come back or grown, based on specific imaging guidelines (iRANO criteria).
• People who are at least 3 weeks past any major surgery, radiation therapy, or cancer drug treatment, and who have recovered from the side effects of those treatments.
• People who are expected to live for at least 12 weeks.
• People who have previously had surgery, radiation therapy, and chemotherapy for their brain tumour.
• People whose cancer has not spread to other parts of the body (excluding non-melanoma skin cancers such as squamous cell or basal cell skin cancer).
• People who have given written consent to participate after being fully informed about the study.
• People who are willing to provide tissue samples (biopsies) as required by the study.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first treatment, and must not be breastfeeding.
• Women who could become pregnant and men who could father a child must agree to use an effective method of birth control during the study.
• People whose kidneys, liver, and blood counts are within acceptable ranges, based on the following lab results (confirm with trial site):
  • Blood creatinine level below 1.5 mg/dL (a measure of kidney function)
  • Liver-related blood values (bilirubin, ALT, AST, GGT, and AP) within acceptable limits
  • Healthy blood cell and platelet counts
  • Normal blood clotting test results
• People who do not speak English are still eligible to participate.
• People with leptomeningeal disease (cancer that has spread to the fluid and tissue surrounding the brain and spinal cord) may be considered for the study (confirm with trial site).

Who may not be able to join:

• People who have received immunotherapy, immune-modifying treatment, or gene therapy within the past 3 months.
• People who have had chemotherapy, radiation, immunotherapy, or any experimental drug for their brain tumour within 3 weeks of the planned study start date.
• People whose tumour appears in multiple separate areas of the brain or involves the brainstem.
• People currently taking immune-suppressing medications, other than steroids used to reduce brain swelling.
• People with leptomeningeal disease whose cancer has spread widely or to the spine, or whose leptomeningeal tumour is large enough to potentially block the flow of cerebrospinal fluid.
• People with liver disease, including cirrhosis or active or long-term hepatitis B or C.
• People with a history of, or current, alcohol misuse or abuse within the past 12 months.
• People with a known allergy or sensitivity to any component of the study treatment, including the gene therapy (HSV-tk vector) or the antiviral medication valacyclovir.
• People who are unable to swallow food or who have an upper digestive tract condition that would prevent them from taking oral medication (valacyclovir tablets).
• People with another active cancer, except for non-melanoma skin cancer, cervical cancer that has not spread, or a previously treated cancer from which the person has been completely disease-free for more than 5 years.
• Women who are pregnant or breastfeeding, or women and men who are able to have children but are not willing to use an effective method of birth control.
• People with an active, uncontrolled infection, a weakened immune system, or a positive HIV test result.
• People under 18 years of age.
• People who are unwilling or unable to follow the study requirements.
• People who have an active CNS toxoplasmosis infection or a condition called Progressive Multifocal Leukoencephalopathy, as shown on brain scans.
• People with an active, untreated skin infection (cellulitis) or untreated wound infection. Infections that are being treated and improving are not an exclusion.
• People with active intravenous drug use or severe opioid misuse.

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