Phase 2 Kidney Cancer Trial, Recruiting NCT05135975 Sponsor: Nationwide Children's Hospital Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05135975
Recruiting Phase 2

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 18 months and 40 years old at the time of enrollment
  • You have one of the specific cancer types listed in the trial, such as neuroblastoma, osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, Wilms tumor, desmoplastic small round cell tumor, or another soft tissue sarcoma, at the required stage or relapse point (confirm with trial site for your specific diagnosis)
  • You are well enough to carry out basic daily activities, as measured by a standard health performance score (confirm with trial site)
  • Your body surface area (a measurement based on your height and weight) meets the minimum size requirement for the study drug dose
  • You have recovered well enough from side effects of any previous cancer treatments
  • Your blood counts (white cells, platelets, and red blood cells) are at acceptable levels
  • Your kidneys are working well enough, based on blood and urine tests
  • Your liver is functioning at an acceptable level, based on blood tests
  • Your heart is healthy enough, with no serious heart rhythm problems, stroke, or heart attack in the past 6 months, and a normal heart electrical reading (ECG)
  • Your blood pressure is within an acceptable range (you may be on one blood pressure medication at a stable dose)
  • Your pancreas enzyme levels are within an acceptable range
  • If you have seizures, you have been on a stable anti-seizure medication for at least 4 weeks that does not interfere with liver enzymes (confirm with trial site for approved medications)
  • You have not had any invasive lung procedures or a collapsed lung within the past 4 weeks
  • You have not had major surgery, serious infection, or significant physical trauma requiring hospitalization within the past 4 weeks
  • Any surgical wounds or incisions are fully healed before enrollment
  • You are able to swallow tablets whole — they cannot be cut or crushed
  • If you are sexually active and able to have children, you and your partner agree to use approved contraception during the study and for 4 months after the last dose
  • If you have had a period, you must confirm you are not pregnant at the time of enrollment
  • You or your legal guardian are able to understand and agree to the study requirements and have signed the consent form
  • You are able to start treatment within 12 weeks of finishing your most recent cancer therapy
  • You are enrolled within 14 days of the imaging scans that confirmed your response to most recent treatment
  • You are able to start treatment within 7 days of being enrolled in the study

Who may not be able to join:

  • You do not have the specific cancer type or disease stage required by the trial
  • Your general health or performance level does not meet the minimum required score
  • You have not recovered sufficiently from side effects of previous treatments
  • Your blood counts, kidney function, liver function, heart function, blood pressure, or pancreas enzyme levels do not meet the required levels
  • You have had a serious heart event (such as a heart attack or stroke) within the past 6 months
  • You are on certain anti-seizure medications that affect liver enzymes (confirm with trial site)
  • You have had an invasive lung procedure or a collapsed lung within the past 4 weeks
  • You have had major surgery, serious infection, or hospitalization due to trauma within the past 4 weeks
  • You have had a central line or port placed, revised, or removed within the past 7 days (a PICC line is an exception — confirm with trial site)
  • You have had a core or fine needle biopsy within the past 7 days
  • You have surgical wounds or incisions that have not fully healed
  • You are unable to swallow tablets whole
  • You are pregnant or unwilling to use contraception during and after the study
  • Additional exclusion criteria exist in the full protocol that are not listed here (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 26 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: Nilay Shah, MD, Nationwide Children's Hospital

Phone: 6147222739

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
Nationwide Children's Hospital
Registry
ClinicalTrials.gov
Start date
20 July 2022
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To evaluate the effect of oral daily cabozantinib, administered for up to 12 months, on the one-year progression-free survival of patients with "ultra-high-risk" pediatric solid tumors.

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: 26 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