Intractable neuroblastoma
Conditions
Interventions
(1) After enrollment, starting valproic acid (VPA) and adjusting VPA dosing to reach and keep the target concentration (100ug/ml). (2) Preparing for 131I-MIBG administration by assessing disease stat
s hematologic status.
Sponsors
National Cancer Research Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. histological proven neuroblastoma 2. ability to control urination and body weight = < 18kg 3. PS (Lansky) >= 50% 4. any radiologically confirmed residual disease which are not shrinking or any tumor associated symptoms, despite prior chemotherapies 5. any diseases evaluable by 123I-MIBG scan performed within 8 weeks 6. any non-irradiated disease with 123I-MIBG uptake which compress spinal cord 7. autologous hematopoietic stem cell product available for re-infusion after MIBG treatment whose quantity is more than 1.5*10^6 CD34+ cells/kg or 1.0*10^6 CD34+ cells/kg if the quality is confirmed within 8 weeks. 8. If the last chemotherapy contains one or more drugs with hematologic dose limiting toxicity (DLT), 7 days or more have passed since last use of anti-tumor agents which are administerd protractedly and 14 days or more have passed since last use of anti-tumor agents which are not administered in protracted way 9.7 days or more have passed since the anti-cancer drug (dosage restriction toxicity is non-hematologic toxicity) 10. No prior irradiation within 14 days if radiation fields is limited. No prior irradiation within 3 months 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. 11. No oral 13-cis-RA within 14 days. 12 Any red blood cell (RCC) transfusion or platlet cell (PC) transfusion history within 7 days from registration or the last RCC or PC transfusion. 13. Normal organ function confirmed by laboratory tests within 14 days 14. No exertional dyspnea and no oxygen supply for everyday life. 15. No need for any anti-epileptics, phycotropics or anti-hypertentsivesexcept VPA during treatment. 16. Written informed consent from patient and/or legal guardian.
Exclusion criteria
Exclusion criteria: 1. active double cancer(synchronous double cancer and metachronous double cancer within 5 disease -free years),excluding carcinoma In situ(lesions equal to Intraepithelial or intramucosal Cancer)judged to have been cured with local treatment 2. active infection requiring systemic medication 3. abnormality in electrocardiogram tested within 28 days,requiring intervention 4. Psychosis which is not appropriate for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who can recover at normal hematologic status without hematopoetic stem cell rescue | — |
Secondary
| Measure | Time frame |
|---|---|
| DLT(profile and incidence) Adverse events profile Proportion of patients maintaining target serum concentration of VPA Clinical benefit rate Response rate identification of problem and solution for perform 131I-MIBG therapy | — |
Countries
Japan
Contacts
Public ContactHiroshi Kawamoto
National Cancer Research Center Hospital Division of Pediatric Oncology
Outcome results
None listed