EUCTR2021-002540-67-FR进行中（未招募）1 期
Phase 2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor - MetroWilms-1906
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
- 性别
- All
入选标准
- •- Patient =18 months old and = 35 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 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 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 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- 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 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)
研究者
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