BridgeMD
MetroWilms
EU CTIS ID: 2022-502687-20-00
What this study is testing
First stage: Evaluate the safety and the feasibility of the metronomic chemotherapy regimen (Vincristine/Irinotecan/Etoposide/Temozolomide/ Cis-Retinoic acid in children and teenagers with a relapsed or refractory Wilms tumor. 2nd stage: To evaluate efficacy of metronomic chemotherapy in patients with a relapsed or refractory Wilms tumor, in terms of disease control after two cycles of metronomic chemotherapy (approximately 6 months).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient ≥18 months old and <18 years old
- Sexually active patients must agree to use adequate and appropriate contraception (at least one highly effective contraception or two complementary methods of contraception), 1 month before beginning of treatment while on trial drug and for 7 months after stopping the trial drug for female patients and after 6 months for male patients.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any trial-specific screening procedures according to national guidelines.
- Patient covered by the French "Social Security" regime
- Relapsed or refractory Wilms tumor, histologically proven at diagnosis
- After at least 2 lines of chemotherapy (conventional or high dose, which may include the trial molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
You likely can't join if
- Prior history of other cancer within 5 years
- Target therapy within less than 5 * half-life of the substance prior to inclusion
- Major surgery within 15 days prior to inclusion
- Presence of any NCI-CTCAE v5 grade ≥ 2 cardiac, hepatic, pulmonary or renal toxicity
- Severe myelosuppression
- Severe peripheral neuropathy (grade ≥ 2)
See the full eligibility criteria
- Patient ≥18 months old and <18 years old
- Sexually active patients must agree to use adequate and appropriate contraception (at least one highly effective contraception or two complementary methods of contraception), 1 month before beginning of treatment while on trial drug and for 7 months after stopping the trial drug for female patients and after 6 months for male patients.
- Written informed consent from parents/legal representative, patient, and age-appropriate assent before any trial-specific screening procedures according to national guidelines.
- Patient covered by the French "Social Security" regime
- Relapsed or refractory Wilms tumor, histologically proven at diagnosis
- After at least 2 lines of chemotherapy (conventional or high dose, which may include the trial molecules) or after 1 line for high risk relapse for which there would not be any curative therapy. If 1 line for high risk relapse, the enrolment should be confirmed by coordinators.
- Radiologically measurable or evaluable disease (visible, target or nontarget- lesion on MRI or CT-scan)
- Performance status: Karnofsky performance status (for patients >16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥ 70%.
- Able to take oral medication or nasal gastric tube or authorized gastrostomy
- Adequate biological criteria: • Neutrophils > 1000/mm3 ; Platelets > 75 000/mm3 • Transaminases (ALT/ AST) ≤ 3 times ULN (or ≤ 6 times ULN if liver metastasis); total bilirubin ≤ 2 ULN (except in case of Gilbert's disease)
- Creatinine ≤ 1,5 ULN or clearance ≥ 60 mL/ min/ 1,73m2 (In case of doubt, to be confirm by assessment of cystatin)
- Females of childbearing potential must have a negative seric pregnancy test within 7 days prior to initiation of treatment
- Prior history of other cancer within 5 years
- Target therapy within less than 5 * half-life of the substance prior to inclusion
- Major surgery within 15 days prior to inclusion
- Presence of any NCI-CTCAE v5 grade ≥ 2 cardiac, hepatic, pulmonary or renal toxicity
- Severe myelosuppression
- Severe peripheral neuropathy (grade ≥ 2)
- Fructose intolerance
- Inflammatory bowel chronic disease and/or intestinal obstruction
- Allergy to soy, peanuts
- Patients with demyelinating form of Charcot-Marie-Tooth disease
- Known active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection
- Known hypersensitivity to dacarbazine (DTIC), isotretinoin or to any of the trial drugs, trial drug classes, excipients in the formulation
- Hyperlipidemia and hypervitaminosis A
- Vaccination with a live attenuated vaccine within 1 month prior to inclusion
- Pregnant or breastfeeding patients
- Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
- Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.