CTIS2022-502687-20-00进行中（未招募）1 期
MetroWILMS-1906: Phase 1-2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor - MetroWilms-1906
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •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 study drug and for 6 months after stopping the study drug for both female and male patients, Written informed consent from parents/legal representative, patient, and age-appropriate assent before any study-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 study 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
排除标准
- •Prior history of other cancer within 5 years, 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 study drugs, study 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, 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
研究者
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