Phase 2 Kidney Cancer Trial, Recruiting NCT06368817 Sponsor: Children's Oncology Group Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT06368817
Recruiting Phase 2 🇦🇺 Australian site

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 are between 3 and 29 years old at the time of joining the study
  • You have been newly diagnosed with a specific type of brain tumor called a germinoma, located in the suprasellar region (near the base of the brain) and/or the pineal region (near the center of the brain), confirmed by a tissue sample or specific blood/fluid test results
  • You have two tumor spots (one in the pineal region and one in the suprasellar region), or a pineal tumor along with a condition called diabetes insipidus (a hormone-related condition causing excess thirst and urination), with specific test results within certain ranges (confirm with trial site)
  • You have certain blood/fluid marker levels in a specific range that require a tissue sample to confirm the diagnosis (confirm with trial site)
  • Your tumor is located in the basal ganglia or thalamus (deep brain regions)
  • Your tumor has spread to other areas of the brain, fluid spaces, or spine
  • Your tumor contains a mix of germinoma and mature teratoma (a type of non-cancerous growth)
  • You are well enough to carry out light daily activities, as measured by a standard health performance scale
  • Your eligibility has been confirmed through a central review of your brain scans
  • Your brain MRI (a detailed scan using magnets) was done within 31 days before joining the trial, with and without a special dye (gadolinium)
  • You had a spine MRI with special dye done before joining the trial
  • You are enrolled and starting treatment no later than 31 days after surgery or diagnosis, whichever comes later
  • A sample of your spinal fluid (from the lower back) was collected before joining, unless it was medically unsafe to do so
  • Your spinal fluid and blood were tested for tumor markers before joining the trial
  • Your blood counts are within acceptable ranges (enough white blood cells, platelets, and red blood cells), tested within 7 days before joining
  • Your kidneys are working well enough, based on blood tests or urine tests appropriate for your age, tested within 7 days before joining
  • Your liver is working well enough, based on blood test results within normal ranges, tested within 7 days before joining
  • You are not having breathing difficulties at rest and your oxygen levels are adequate
  • If you have a seizure condition, it is well managed with medication
  • You do not have severe nervous system side effects (confirm with trial site)
  • You are not in a medical emergency such as a coma, ongoing seizure, or on a breathing machine before joining
  • If you have HIV, your virus levels are undetectable and you are on effective treatment

Who may not be able to join:

  • Your tumor contains certain aggressive cancer cell types, such as yolk sac tumor, embryonal carcinoma, choriocarcinoma, malignant or immature teratoma, or a mixed germ cell tumor
  • Your tumor is made up only of mature teratoma and your tumor marker tests came back normal
  • You have already received any cancer treatment for this tumor other than surgery or steroids
  • You are currently pregnant (note: pregnancy tests may give false results due to the tumor itself — the trial site will follow their own guidelines to check)
  • You are breastfeeding and plan to continue breastfeeding during the study
  • You are sexually active and able to have children but have not agreed to use effective birth control for the whole time you are in the study
  • You or your parent/legal guardian has not signed the required consent form agreeing to take part
  • The study does not meet all required legal and regulatory guidelines for your institution (confirm with trial site)

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mohamed S Abdelbaki, Children's Oncology Group

Australian sites

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales
(02) 4985 5180
Sydney Children's Hospital, Randwick, New South Wales
(02) 9382-1721
The Children's Hospital at Westmead, Westmead, New South Wales
61-2-9845 1400
Queensland Children's Hospital, South Brisbane, Queensland
61 7 3068 1111
Royal Children's Hospital, Parkville, Victoria
61 3 9345 5656
Perth Children's Hospital, Perth, Western Australia

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

Status
Recruiting
Phase
Phase 2
Sponsor
Children's Oncology Group
Registry
ClinicalTrials.gov
Start date
22 October 2024
Est. completion
4 November 2033

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-free survival (EFS) (Stratum I)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov