Phase 2 Kidney Cancer Trial, Recruiting NCT05384821 Sponsor: Centre Oscar Lambret Condition: Kidney Cancer
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Phase 2 Kidney Cancer Trial, Recruiting

NCT05384821
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:

  • Children and young people aged 18 months to 17 years old
  • People who have been diagnosed with Wilms tumor (a type of kidney cancer) that has come back or stopped responding to treatment, where the diagnosis was confirmed by a tissue sample at the time of first diagnosis
  • People who have already received at least 2 rounds of chemotherapy (standard or high-dose), or at least 1 round in cases where the relapse is considered high risk and no curative treatment options remain (enrolment in the 1-line case must be confirmed by trial coordinators)
  • People whose disease can be seen and measured on an MRI or CT scan
  • People who are well enough to carry out most normal daily activities, as measured by standard performance scoring tools used for their age group (confirm with trial site)
  • People who are able to take medication by mouth, through a tube placed through the nose into the stomach, or through an approved feeding tube into the stomach
  • People whose blood counts meet the required levels — specifically, a sufficient number of infection-fighting cells (neutrophils) and blood clotting cells (platelets)
  • People whose liver function test results are within an acceptable range, with some allowance if liver spread is present (confirm with trial site)
  • People whose kidney function is within an acceptable range, based on blood tests or urine clearance measurements
  • Females who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment
  • People who are sexually active must agree to use reliable contraception starting 1 month before treatment, throughout the trial, and for 7 months after finishing treatment for females, or 6 months after for males
  • People (or their parents or legal guardians) who have given written agreement to take part, in line with national guidelines
  • People who are covered by the French Social Security system

Who may not be able to join:

  • People who have had another type of cancer in the past 5 years
  • People who have had chemotherapy or radiotherapy to the areas being measured in the trial within the past 3 weeks before joining
  • People who have recently received a targeted therapy, depending on how long that specific medication stays active in the body (confirm with trial site)
  • People who have had major surgery within the past 15 days before joining
  • People who have significant ongoing heart, liver, lung, or kidney side effects from previous treatment (graded as moderate or above on a standard medical scale)
  • People with severely reduced bone marrow function affecting blood cell production
  • People with significant nerve damage affecting the hands or feet (graded as moderate or above)
  • People with a known intolerance to fructose (a type of sugar)
  • People with a chronic inflammatory bowel condition or a blockage in the intestines
  • People diagnosed with the demyelinating form of a nerve condition called Charcot-Marie-Tooth disease
  • People with a known active hepatitis infection, HIV, or any other infection that is not currently under control
  • People with a known allergy or sensitivity to dacarbazine, isotretinoin, or any of the other trial medications or their ingredients
  • People with high levels of fats in the blood (hyperlipidemia) or excess vitamin A in the body
  • People who have received a live vaccine within 1 month before joining
  • People who are pregnant or breastfeeding
  • People who would be unable to attend the required medical follow-up appointments due to geographic, social, or personal circumstances

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 6 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: Hélène SUDOUR-BONNANGE, MD, Centre Oscar Lambret

Phone: +33 (0)3 20 29 59 18

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
Centre Oscar Lambret
Registry
ClinicalTrials.gov
Start date
14 September 2022
Est. completion
1 May 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Disease control

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: 6 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