A phase II study of the combination of gemcitabine with 131I-MIBG therapy for children with neuroblastoma without other treatment options.
- Conditions
- relapsed or progressive neuroblastoma in pediatric patients of 1 to 18 yearsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-007974-45-NL
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 47
- relapsed or progressive neuroblastoma
- age 1 up to 18 years
- measurable primary and/or metastatic disease, stage 3 and 4
- evidence of sufficient MIBG uptake in bone or soft tissue
-lansky play score over 60 or ECOG 1
- adequate organ function
- life expectancy > 6 weeks
- wash out of prior therapy of 3 weeks; (1 week if vincristine, 6 weeks in case of nitrosureas); 6 months in case of ASCT
- written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 47
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-other anti-tumour therapy
- symptomatic brain metastasis
- contra-indication for nuclear isolation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method