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

CPT-PED-05 administrative office0 sites30 target enrollmentJanuary 27, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 27, 2006

End Date

April 2, 2009

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

CPT-PED-05 administrative office

•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