advanced and recurrent neuroblastoma
Conditions
Interventions
Fourteen-days oral administration of 13-cis RA every 28 days repeated up to 6 cycles, and concurrent with daily administration of VPA orally to maintained the target concentration.
Sponsors
National Cancer Research Center Hospital Division of Pediatric Oncology
National cacncer center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.neuroblastoma(historical) 2.The following status of patients completing standard treatment a. Recurrence, after 2nd-line chemotherapy. b. Stage2 or 3 with residual disease c. Stage4 3. Prior history of autologous hematopoietic stem cell transplantation. 4. No prior history of allogeneic hematopoietic stem cell transplantation. 5. More than 7 days after chemotherapy which has hematological DLT. 6. More than 7 days after chemotherapy which has non-hematological DLT 7. More than 21 days after radiation therapy 8.More than 14 days after surgery 9.More than 14 days after 13-cis-RA 10. More than 7 days after erythrocyte or platelet transfusion 11.PS>=50% 12.Any organ function is maintained. 13.No oxygen demand is needed 14.no difficulty to take 15mm capsule. 15.legal adult:written informed consent. 16.16 years and over,but, no legal adult: written informed consent from both patient and legal guardian. 17.15 years and under: written informed consent from 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. respiratory or heart disorder requiring oxygen supply,except from malignant pleural effusion. 5. women during pregnancy or breast-feeding. 6. Psychosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD(maximum tolerated dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| DLT(Identification and generating rate) Adverse events profile VPA(target serum concentration ) Response rate Progression free survival Overall survival Proportion of the patients who complete all six courses for all registered. Pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactNaoko Yasui
National Cancer Research Center Division of Pediatric Oncology
Outcome results
None listed