2022-502687-20-00招募中2 期
MetroWILMS-1906: Phase 1-2 trial evaluating metronomic chemotherapy in patients with relapsed or refractory Wilms tumor
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- -Dose limiting toxicity (DLT) over the first cycle (12 weeks, or more in case of temporary discontinuation). - Disease control (complete response, partial response or stable disease) after 2 cycles of treatment, measured by the progression-free survival (PFS), approximately 6 months after inclusion.
研究概览
简要总结
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).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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 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
排除标准
- •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
结局指标
主要结局
-Dose limiting toxicity (DLT) over the first cycle (12 weeks, or more in case of temporary discontinuation). - Disease control (complete response, partial response or stable disease) after 2 cycles of treatment, measured by the progression-free survival (PFS), approximately 6 months after inclusion.
-Dose limiting toxicity (DLT) over the first cycle (12 weeks, or more in case of temporary discontinuation). - Disease control (complete response, partial response or stable disease) after 2 cycles of treatment, measured by the progression-free survival (PFS), approximately 6 months after inclusion.
次要结局
- The feasibility of evaluated therapy will be assessed in terms of frequency of dose reductions or temporary stops of treatment, summarized by the relative dose intensity for each drug, and reasons for permanent discontinuation.
- Progression free survival, computed as the time interval between trial entry and date of progression (according to central review, and using RECIST 1.1) or death from any cause. Patients still alive without evidence of disease progression at the time of their last visit will be censored at that date. We will use similar rules for censoring as for the primary endpoint.
- Overall survival, computed as the time interval between trial entry and death from any cause. Patients still alive at the time of their last visit will be censored at that date.
- Health-Related Quality of life (HRQoL) will be assessed using the age-appropriate Kindl® Quality of Life questionnaires (self- and proxy-assessment) (Ravens-Sieberer and Bullinger, 1998), with three time points (baseline and approximately at weeks 7 and 13).
- Tumor response based on CT-scan or MRI imaging, using the same method over the whole trial period, and evaluated by central radiological review, using RECIST 1.1 criteria after each cycle of treatment (every 3 months approximately). The early response is based on the evaluation after one cycle. The best response is measured over the whole treatment duration.
- Adverse events occurring from start of treatment until the end of trial treatment (plus 30 days) will be reported and graded using the NCI-CTCAE v5.0 classification, excluding those unequivocally related to the underlying disease or its progression.
研究者
Clinical Research Sponsor Unit
Scientific
Centre Oscar Lambret
研究点 (16)
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