A phase II study of the combination of gemcitabine with 131I-MIBG therapy for children with neuroblastoma without other treatment options.
Recruiting
- Conditions
- neuroblastoma, children, relapsed, progressive
- Registration Number
- NL-OMON24917
- Lead Sponsor
- Academisch Medisch Centrum Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
1. Histological proven neuroblastoma;
2. Measurable primary and/or metastatic disease;
Exclusion Criteria
1. Received treatment within the last 21 days with an
investigational or conventional anti-cancer drug;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of efficacy as measured by response rate (and time-to-event measurements).
- Secondary Outcome Measures
Name Time Method Characterization of safety and toxicity profile.