intractable neuroblastoma
Conditions
Interventions
Treatment M CSF regimen (ch14.18 10-20h div d4-7, mirimostim 2h div d1-14) and IL2 regimen (ch14.18 10-20h div d8-11, teceleukin 24h div d1-4, d8-11) are performed alternately, starting CSF regimen u
Sponsors
A study group for "Research on Applying Health Technology" of health and Labor Sciences Research Grants
investigational agent suppliers: OHARA Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Shionogi &
Co., Ltd., Japan Chemical Research Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histogically proven neuroblastoma 2. Prior history of high-dose chemotherapy (HDC). 3. (phaseI): B. is required. (phaseIIa): A. or B. is required. A. No prior chemotherapy after HDC, 180 days or less after stem-cell transplantation and none of the followings: radiologically confirmed progressive disease, moderate bone marrow invasion, or, high urine HVA or VMA concentration B. One or more prior chemotherapy after HDC and at least one of the followings: one and more radiologically confirmed progressive site(s), bone marrow invasion, high urine HVA or VMA concentration, and tumor associated symptom(s) 4. PS(Lansky or Karnofsky) >= 50% 5. 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. 6. 7 days or more have passed since last chemotherapy which does not contain any drugs with hematologic DLTs 7. 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. 8. No prior allogeneic hematopoietic stem cell transplantation 9. Normal organ function confirmed by laboratory tests within 14 days 10. No intracranial hemorrhagic episode within one week and platelet count >= 50000/ul and Hb >= 8.0g/dl more than three days after last blood transfution. 11. 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. 14 days or less after last administration of systemic steroids 4. 28 days or less after last administration of immunogloblin 5. Any abnormalities in electrocardiogram tested within 28 days,which require intervention. 6. Fractional Shortning < 30% or Ejection Fraction < 55% by echocargiogram within 28 days. 7. Respiratory or heart disorder requiring oxygen supply 8. Possibilly/confirmed pregnant or lactating 9. Impossible for sexually active patients to use one of effective methods of birth control during and 6 month after treatment 10. Psychosis which is not appropriate for participating in this study. 11. allergy or predisposition for any elements involved in all the investigational agents in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT of ch14.18, teceleukin, mirimositim, filgramostim (phaseI) Proportion of completing 5 courses of M regimen and G regimen (phaseIIa) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. adverse events profile 2. clinical benefit rate. response rate. progression free survival. disease free survival. overall survival. 3. pharmacokinetics and dose-response for ch14.18 and teceleukin 4. antibody dependent cell-mediated cytotoxicity activity 5. anti-chimera antibody response proportion | — |
Countries
Japan
Contacts
Public ContactHiroshi Kawamoto
National Cancer Research Center Division of Pediatric Oncology
Outcome results
None listed