In short
There are currently 2 ongoing clinical trials investigating new treatment approaches for nephroblastoma in children and teenagers. These studies are testing different combinations of chemotherapy drugs to improve outcomes for patients with advanced or relapsed kidney cancer. (Also known as: Wilms Tumor)
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Study Comparing Vincristine, Actinomycin-D, and Doxorubicin with Vincristine, Carboplatin, and Etoposide for Stage IV Childhood Kidney Cancer Patients
- Study on Metronomic Chemotherapy for Children and Teenagers with Relapsed or Refractory Wilms Tumor Using Vincristine, Irinotecan, Etoposide, Temozolomide, and Isotretinoin
- Germany
- Netherlands
Study Comparing Vincristine, Actinomycin-D, and Doxorubicin with Vincristine, Carboplatin, and Etoposide for Stage IV Childhood Kidney Cancer Patients
This trial is comparing two different chemotherapy combinations for children with Stage IV kidney cancer that has spread to other parts of the body, particularly the lungs. The study aims to determine whether a new experimental treatment is as effective as the current standard treatment in shrinking tumors before surgery.
Who can participate:
- Children between 3 months and 18 years old
- Patients with a newly diagnosed kidney tumor that has spread to other parts of the body
- At least one tumor nodule of 3 mm or larger visible on chest or abdominal scans
- Patients must be able to follow the study schedule and have no existing heart or uncontrolled liver problems
- Parents or legal guardians must provide written consent
Who cannot participate:
- Patients without Stage IV kidney cancer that has spread
- Patients who are not newly diagnosed
- Those who fall outside the required age range
- Patients unable to follow study procedures or take medications as required
- Patients with other medical conditions that would make participation unsafe
What the trial involves: Participants will be randomly assigned to receive either the standard treatment combination of Vincristine, Actinomycin-D, and Doxorubicin, or the experimental combination of Vincristine, Carboplatin, and Etoposide. Both groups will receive six weeks of chemotherapy before surgery to remove the tumor, followed by an additional nine weeks of chemotherapy after surgery. The medications are given directly into a vein. Throughout the study, doctors will monitor how well the cancer responds to treatment using imaging tests and assess any side effects.
Investigational drugs: The trial uses Vincristine, which stops cancer cell growth by preventing cell division; Actinomycin-D, which blocks protein production in cancer cells; Doxorubicin, which damages cancer cell DNA; Carboplatin, which prevents cancer cells from dividing by damaging their DNA; and Etoposide, which stops cancer cells from multiplying by blocking a key enzyme.
Study on Metronomic Chemotherapy for Children and Teenagers with Relapsed or Refractory Wilms Tumor Using Vincristine, Irinotecan, Etoposide, Temozolomide, and Isotretinoin
This trial is testing a treatment approach called metronomic chemotherapy for children whose kidney cancer has returned or has not responded to previous treatments. Metronomic chemotherapy uses lower doses of drugs given more frequently, which may help control the disease with fewer side effects.
Who can participate:
- Patients between 18 months and 18 years old
- Patients with confirmed Wilms tumor that has relapsed or is not responding to treatment
- Patients who have tried at least two different chemotherapy treatments, or one treatment if the tumor is high risk with no other cure available
- The disease must be visible on imaging tests like MRI or CT scans
- Performance status of at least 70% on appropriate scales for age
- Patients must be able to take oral medications
- Must meet specific blood test requirements for white blood cells, platelets, liver and kidney function
- Females of childbearing age must have a negative pregnancy test
- Sexually active patients must agree to use effective birth control
Who cannot participate:
- Patients with a different type of cancer other than Wilms tumor
- Adults who are not within the specified age range
- Patients whose cancer is not relapsed or refractory
- Patients who cannot safely receive the specific chemotherapy drugs used in the study
- Patients unable to follow study procedures or attend regular check-ups
- Pregnant or breastfeeding patients
- Patients with other serious health conditions that could interfere with treatment
What the trial involves: Participants will receive a combination of five medications over approximately six months. Vincristine and Irinotecan are given through a vein, while Etoposide, Temozolomide, and Isotretinoin are taken by mouth. The study has two stages: the first assesses safety and feasibility over 12 weeks, and the second evaluates how well the treatment controls the disease over about 6 months. Regular imaging tests will track tumor response, and quality of life will be assessed using age-appropriate questionnaires at baseline and during treatment.
Investigational drugs: The trial uses Vincristine, which stops cancer cell growth; Irinotecan, which interferes with cancer cell DNA to prevent multiplication; Etoposide, which slows cancer cell growth; Temozolomide, which damages cancer cell DNA leading to cell death; and Isotretinoin (Cis-Retinoic Acid), a form of vitamin A that helps control cancer cell growth and spread.
Summary
These two clinical trials represent important research efforts to improve treatment for children with kidney cancer. The first trial is a large international study taking place across seven European countries, comparing two different chemotherapy combinations for newly diagnosed Stage IV disease. This multinational approach allows for broader patient recruitment and may lead to new standard treatment options.
The second trial, conducted in France, focuses specifically on patients whose cancer has returned or has not responded to previous treatments. This study tests a metronomic chemotherapy approach, which uses lower, more frequent doses of multiple drugs. This may offer an option for patients who have limited alternatives available.
Both trials use Vincristine and Etoposide, suggesting these drugs remain important in treatment regimens. The studies are designed to carefully monitor both effectiveness and side effects, with regular imaging and quality of life assessments to ensure patient safety and well-being throughout treatment.
