Relapse or refractory pediatric solid tumor
Conditions
Interventions
Tamibarotene is orally administered twice a day in 1-14or1-21 days. 28days per a course,up to 8 courses.
Sponsors
National Cancer Center Hospital East Division of Pediatric Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Aged 3 to 30 years old 2)Histologically proven sarcoma, blastoma, germ cell tumors, CNS except malignant lymphoma 3)Relapse or progression following disease-specific standard chemotherapies 4)Site by With evaluable disease 5)PS(Karnofsky or Lansky) >= 50% 6)7 days or more have passed since last use of anti-tumor agents which are continuously-administered and 14 days or more have passed since last use of anti-tumor agents which are not administered continuously 7)No prior irradiation within 12 weeks if radiation fields contain either whole brain and spine, whole abdomen, whole lung, whole body, or more than 50% of pelvis. No prior irradiation within 6 weeks if radiation fields contain either less than 50% of pelvis, or 5 or less vertebras. No prior irradiation within 14 days if radiation fields are limited. 8)No difficulty to take soft capsule or tablet 9)Normal organ function confirmed by laboratory tests within 14 days 10)Written informed consent from patient and/or legal guardian
Exclusion criteria
Exclusion criteria: 1)Synchronous or asynchronous(within 5 years)other cancer except carcinoma in situ or intramucosal carcinoma 2)Active infection requires systemic therapy 3)Any abnormalities in electrocardiogram tested within 28 days, which require intervention 4)Respiratory disorder requiring oxygen supply 5)Woman during pregnancy, or impossible to discontinue breast-feeding from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Woman without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Man without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment. 6)Severe psychiatric disorder 7)Patients with history of allergy to tamibalotene 8)Patients with history of treatment with tamibarotene 9)In patients having a brain tumor or metastasis to brain, a symptom with the intracranial hypertension is poor in control 10)Patients otherwise considered ineligible for enrollment in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adverse events 2)Clinical Benefit Rate(CBR) 3)Pharmacokinetics and dose-response for tamibarotene | — |
Countries
Japan
Contacts
Public ContactAkihiro Sato
National Cancer Center Hospital East Office of Clinical Research Support
Outcome results
None listed