Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)

Launched by CENTRE OSCAR LAMBRET · May 18, 2022

Keywords

ClinConnect Summary

The MetroWilms-1906 clinical trial is investigating a treatment called metronomic chemotherapy for children and young adults with Wilms tumor, a type of kidney cancer that has come back or did not respond to previous treatments. The study aims to see how effective this new approach is at controlling the disease after patients receive two cycles of this chemotherapy. This trial is currently recruiting participants aged between 18 months and 17 years who have had at least two prior treatments or one for high-risk cases without a chance for a cure. To join, patients need to have measurable signs of their cancer and be in good enough health to take medications.

Participants in this trial can expect to receive the metronomic chemotherapy and will be closely monitored for how well it works in controlling their cancer. It’s important for families to know that there are specific requirements to be eligible, such as having a certain level of blood cells and organ function. The trial also requires that participants have a negative pregnancy test if they are females who can become pregnant, and they must agree to use effective birth control. Overall, this study is an opportunity for young patients with challenging cases of Wilms tumor to access a potential new treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥18 months old and ≤ 17 years old
• • 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 non-target-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.
• • 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
• Exclusion Criteria:
• • Prior history of other cancer within 5 years
• • Chemotherapy or radiotherapy of target lesion within 3 weeks prior to inclusion
• • 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
• • 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)