Phase 1 Kidney 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:

• People aged 1 year old up to and including 30 years old at the time treatment begins.
• People who have been confirmed by tissue testing to have a solid tumour or brain/spinal cancer that has come back or stopped responding to treatment.
• People aged 16 and over who score at least 50 on a standard health and activity scale called the Karnofsky scale; people under 16 who score at least 50 on a similar scale called the Lansky scale (these scores reflect being able to manage at least some daily activities).
• People who may have previously received vincristine, irinotecan, or temozolomide on their own, but not irinotecan and temozolomide given together as a combined treatment.
• People who have not received bone-marrow-suppressing chemotherapy in the past 3 weeks, or a specific type called nitrosourea chemotherapy in the past 6 weeks.
• People who have not received a white blood cell growth factor injection (G-CSF) in the past 3 days, or a longer-acting version (peg-filgrastim) in the past 7 days.
• People who have finished any biological cancer therapy at least 21 days ago, or at least 5 half-lives of that therapy ago, whichever is longer (confirm with trial site).
• People who finished local radiation therapy at least 14 days ago; or at least 6 months ago if whole-body, brain-and-spine, or large pelvic radiation was given; or at least 6 weeks ago if other significant bone marrow radiation was given.
• People who have had a stem cell transplant, provided there is no active graft-versus-host disease, no ongoing need for immune-suppressing drugs, and at least 3 months have passed since the bone marrow recovered.
• People whose blood counts meet the required levels: neutrophils at least 1,000 cells/mcL (or at least 750 cells/mcL for those with known cancer spread to the bone marrow), platelets at least 100,000/mcL without a transfusion in the past 7 days, and haemoglobin at least 8 g/dL.
• People whose liver is functioning adequately, based on blood test results for bilirubin, liver enzymes (ALT), and albumin being within acceptable ranges for age.
• People whose kidneys are functioning adequately, based on either a kidney filtration rate above 70 ml/min/1.73m², or a blood creatinine level within the acceptable range for their age and sex.
• People aged 18 or over who have signed written informed consent; for those under 18, a parent or guardian must sign consent, unless the patient is legally independent. Where appropriate, the young person's own agreement should also be obtained in line with the trial site's guidelines.

Who may not be able to join:

• People who are pregnant or breastfeeding, due to known risks the trial medications pose to a developing baby.
• People with a brain or spinal tumour who have been taking corticosteroid medications at an increasing or unstable dose during the 7 days before treatment is due to start.
• People who are currently receiving any other cancer treatment.
• People who have a known allergy or intolerance to any of the trial drugs: vincristine, irinotecan, temozolomide, or vorinostat.
• People who have a known allergy or intolerance to a group of antibiotics called cephalosporins.
• People who have any uncontrolled infection, a positive blood culture result within 48 hours before joining the trial, or a current or recently treated Clostridioides difficile (C. diff) gut infection.
• People who have taken valproic acid or any other drug in the class known as histone deacetylase inhibitors within the 2 weeks before enrolment.
• Children with a genetic condition called Neurofibromatosis Type 1 who would be entering the trial as a treatment for a low-grade brain tumour called a low-grade glioma.

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