Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 291 participants across six treatment groups: Surgery (68 people), UH-1 (98 people), Window/UH-1 (7 people), UH-2 (10 people), Regimen I (78 people), and Regimen DD-4A (30 people). The trial was measuring outcomes for children with certain rare kidney tumours — specifically a type called diffuse anaplastic Wilms' tumour and another called malignant rhabdoid tumour — looking at how long participants went without their disease getting worse (called "event-free survival"), how often tumours responded to treatment, and rates of certain serious side effects. The reported data shows the following figures for the main (primary) outcomes. For diffuse anaplastic Wilms' tumour, the four-year overall survival percentage was reported as 76.1% in the UH-1 group, 25.0% in the Window/UH-1 group, and 87.5% in the UH-2 group. For malignant rhabdoid tumour patients in the UH-1 group, the four-year overall survival figure was reported as 38.9%. In terms of how tumours responded during an early "window" treatment phase, the reported data shows a response rate (tumours that shrank significantly or disappeared) of 71% across the combined window groups. For participants on Regimen DD-4A, the four-year event-free survival probability was reported as 100%. Regarding serious side effects tracked as a primary outcome, the reported data shows 4.9% of participants in the combined UH groups experienced severe heart-related toxicity, 4.9% experienced a serious liver condition called Sinusoidal Obstruction Syndrome, and no treatment-related deaths were reported (0%). For a secondary (additional) outcome, 23 participants in the UH-1 group and 1 participant in the Window/UH-1 group were found to have a specific genetic change (INI1 mutation) in their tumour tissue, though the data for several other secondary outcomes was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38396300) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Kidney Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been recently diagnosed with one of these specific kidney-related cancers: focal or diffuse anaplastic Wilms' tumor, clear cell sarcoma of the kidney, malignant rhabdoid tumor (in the kidney or elsewhere in the body), or certain types of renal cell carcinoma (kidney cancer)
- Your tissue samples must be sent for review by a central laboratory within 7 days of enrollment
- You must be able to start the treatment in this trial within 14 days of your surgery or biopsy, unless your doctor determines it is medically unsafe to do so
- You must have a reasonable level of physical functioning, as measured by standard performance scales used by your medical team (confirm with trial site)
- Your liver function blood test results must be within an acceptable range (no more than 1.5 times the upper normal limit for your age)
- Your liver enzyme levels (AST and ALT) must be below 2.5 times the upper normal limit for your age
- Your heart must be functioning well enough, as shown by either an echocardiogram (ultrasound of the heart) or a heart scan (confirm with trial site)
- If you are a female patient who could become pregnant, you must have a negative pregnancy test before joining
- You, your parents, or your legal guardian must sign a written consent form agreeing to take part in the study
- All required legal and regulatory standards for the study must be met
Who may not be able to join:
- You have already received chemotherapy or radiation therapy before joining this trial, unless you were previously enrolled in specific related studies (AREN0532 or AREN0533) and received pre-surgery chemotherapy for what was initially thought to be a different type of Wilms' tumor (confirm with trial site)
- If you have pediatric renal cell carcinoma (kidney cancer in a child), you may still be eligible even if you previously received chemotherapy for a different cancer or non-cancer condition — but this needs to be confirmed with the trial site
- If you are breastfeeding, you must agree to stop before joining the trial
- If you are sexually active and could become pregnant, you must agree to use effective birth control during the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Jeffrey Dome, MD, Children's Oncology Group
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT); Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors; Response Rate; Event Free Survival Probability; Toxicity Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.