Phase 3 Kidney 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 are already enrolled in a related screening study called APEC14B1 and have agreed to its eligibility screening section before joining this trial.
• People who are under 30 years old at the time of joining.
• People who have been newly diagnosed with Stage I, II, III, or IV Favorable Histology Wilms Tumor (a type of kidney cancer), confirmed by a central medical review team, with a qualifying risk category assigned through APEC14B1.
• People who receive their official risk category assignment within 14 days of their initial surgery or biopsy, and who enroll in this trial by that same 14-day point (special exceptions may apply in certain circumstances — confirm with trial site).
• People whose tumor sample has been sent, or will be sent, to an approved laboratory for specific genetic testing to look for certain chromosome changes.
• People who had their kidney removed upfront (rather than after chemotherapy) and had at least one lymph node removed and confirmed as a lymph node by the central review team.
• People over 16 years old who have a performance score of 50 or higher on the Karnofsky scale, meaning they are able to care for most of their own needs (confirm with trial site).
• People aged 16 or younger who have a performance score of 50 or higher on the Lansky scale, a similar measure of daily functioning for children (confirm with trial site).
• People who will receive chemotherapy and have liver function blood test results within acceptable ranges, tested within 7 days before joining.
• People who will receive chemotherapy and have heart function results showing the heart is pumping adequately, tested within 7 days before joining (this applies specifically to Stage IV patients at the start, and to Stage II/III patients if they are later assigned to a treatment arm involving a specific heart medication).
• People living with HIV who are on effective HIV treatment and have had an undetectable level of the virus in the last 6 months.
• People (and/or their parents or legal guardians) who are willing and able to sign a written consent form.
• People whose participation meets all relevant institutional, FDA, and NCI requirements.

Who may not be able to join:

• People diagnosed with Stage V Bilateral Wilms Tumor (cancer affecting both kidneys at the same time).
• People who, in the opinion of the medical team, would not be able to follow the study procedures.
• People who have an uncontrolled ongoing illness, including but not limited to symptomatic heart failure.
• People with Stage I Favorable Histology Wilms Tumor who have a known or suspected genetic condition or syndrome that increases the risk of Wilms Tumor (such as Beckwith-Wiedemann Spectrum, WAGR, Denys-Drash, or several others), or who have certain tumour patterns in the kidney — these people are not eligible for the surgery-only treatment arm of the trial (confirm with trial site for full list of conditions).
• People who had a partial kidney removal (rather than full removal) at initial diagnosis are not eligible for the surgery-only treatment arm.
• People whose cancer had spread only to the lungs, and where all visible lung tumours were completely removed before enrolling, with at least one confirmed as cancer on pathology.
• People diagnosed with a nerve condition called Charcot-Marie-Tooth syndrome.
• People who have already received chemotherapy or radiation therapy aimed at the current tumour, unless it was given as an emergency medical necessity.
• People who may need a specific heart medication (doxorubicin) as part of this trial but who have already received that same medication for a different diagnosis in the past.
• People currently receiving chemotherapy for a different medical condition at the same time.
• People who are pregnant, as several of the study drugs may harm an unborn baby. A pregnancy test is required for anyone of childbearing potential.
• People who are breastfeeding and plan to continue breastfeeding during the trial.
• People who are sexually active and could become pregnant or cause pregnancy, and who have not agreed to use an effective method of contraception throughout their time in the study.

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