Phase Ib study of 131I-metaiodobenzylguanidine(MIBG) therapy with Valproic Acid(VPA) for high risk or recurrent neuroblastoma
Phase 1
- Conditions
- Intractable neuroblastoma
- Registration Number
- JPRN-UMIN000012032
- Lead Sponsor
- ational Cancer Research Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who can recover at normal hematologic status without hematopoetic stem cell rescue
- Secondary Outcome Measures
Name Time Method 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