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

UMIN ID: C000000314

Registered date:27/01/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Recurrent or progressive pediatric solid tumors (except for malignant lymphoma)
• Date of first enrollment: 2006/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Phase1 : Level1(4mg/m2/day) - level5 (6mg/m2/day). Evaluate 3 - 6 cases for each level. Fix certain dose level as MTD, where DLT once occurred. Define recommended dose (RD) at one rank lower level than MTD. Phase2 : Adopt RD of Phase1. 3hr-div, day 1,2,3 and 8,9,10. 21days consist one cycle. Repeat up to 8 cycles unless the trial goes against discontinuation criteria of protocol triatment.

Outcome(s)

• Primary Outcome: Phase I: dose limiting toxicity, response rate including patients entered in phase II part Phase II: response rate including patients entered in phase I part
• Secondary Outcome: Progression-free survival, survival duration (median, 1-year survival rate), frequency of side effects, frequency of adverse events, severity and reversibility of each events, dose-response relationship, dose intensity, pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: 2years-old
• Age maximum: 18years-old
• Gender: Male and Female
• Exclude 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 5years, 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

Related Information

• Primary Sponsor: CPT-PED-05 administrative office
• Source(s) of Monetary Support: Center for Clinical Trials, Japan Medical Association