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

Phase 1

Completed

• Conditions: Recurrent or progressive pediatric solid tumors (except for malignant lymphoma )

• Registration Number: JPRN-jRCT1091220004
• Lead Sponsor: CPT-PED-05 administrative office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-27
• Study Completion: 2009-04-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified