Feasibility and pharmacokinetic study of ch14.18 immunotherapy using teceleukin and CSF (mirimostim, filgrastim) for neuroblastoma
- Conditions
- intractable neuroblastoma
- Registration Number
- JPRN-UMIN000012001
- Lead Sponsor
- A study group for "Research on Applying Health Technology" of health and Labor Sciences Research Grants
- Brief Summary
Sixteen (8 each in R1 and R2) recurrent pts were enrolled. All two DLT (Grade4 thrombocytopenia, Grade3 hypokalemia) of 12 pts in pI occurred only on IL2 regimen (IL2:level0, ch14.18: level1). The recommended dose (RD) of IL2 was level0 (0.75 million IU/m2 (d1-4) and 1 million IU/m2 (d8-11)). the RDs of All the other agents were determined at level1 (Dmab:17.5mg/m2, M-CSF: 6 million IU/m2, G-CSF: 5 ug/kg). SAE were 3 blood stream infections, 1 Grade 3 pancreatitis (inflammation around metastatic lesion in pancreas), 2 upper respiratory infection and 1 Grade4 transaminitis. 7/8 in R1 and 5/8 in R2 completed more than 5 cycles. All eleven consented pts recieved 7 cycles. The result of PK analysis is presented in the following table. Augmentation of ADCC was confirmed in both R1 and R2. More than half pts were positive for HACA assay.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method