Phase I-II clinical trial of irinotecan hydrochloride (CPT-11) for refractory pediatric solid tumors - CPT-PED-05

CPT-PED-05 administrative office0 个研究点目标入组 30 人开始时间: 2006年1月27日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) a patient who obtains diagnosis with the disease targeted in this trial with histological or cytological diagnosis
•2) equal to, or more than 2 year-old, and less than 18 year-old of age
•3) a patient who recurred or refractory to standard chemotherapy, or a patient who is unable to continue standard chemotherapy because of toxicities
•4) a patient with measurable lesion (by RECIST)
•5) more than 28 days period from the last date of therapy
•6) a patient with at least 3 months of life-expectancy
•7) performance status (Karnofsky/Lansky) equals to, or more than 50 points
•8) a patient without serious organ failure
•9) inpatient treatment at least during 1st course of chemotherapy
•10) Informed consent from parents or guardian

•1) a patient who received transfusion, blood products, or hematopoietic growth factors such as G-CSF within 7 days prior to the registration
•2) a patient who has another active malignant disease, which is untreated or whose control period is less than 5 years, in different site
•3) a patient with symptomatic metastasis to central nervous system, or a patient with primary central nervous system tumor
•4) a patient who is complicated with serious disease as below;
•1. infection, diarrhea, ileus, paralytic ileus
•2. malignant fluid retention (pleural effusion, ascites, pericardiac effusion)
•3. interstitial pneumonia or pulmonary fibrosis
•4. cardiac disease
•5. other disease which possibly interfere the trial
•5) a patient who is pregnant, during breast-feeding, possibly pregnant, or willing to be pregnant
•6) past history of serious drug allergy
•7) past history of administration of CPT-11
•8) a patient who was judged as inappropriate for the trial

发起方

CPT-PED-05 administrative office