Recurrent or progressive pediatric solid tumors (except for malignant lymphoma)
Conditions
Interventions
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 th
Sponsors
CPT-PED-05 administrative office
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAtsushi Makimoto
National Cancer Center Hospital Division of Pediatric Oncology
Outcome results
None listed