EUCTR2007-007974-45-DE
Active, not recruiting
Not Applicable
Phase II trial of the addition of gemcitabine to 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma - MIBG-Gem
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- relapsed or progressive neuroblastoma in pediatric patients of 1 to 18 years
- Sponsor
- AMC
- Enrollment
- 47
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- other anti\-tumour therapy
- •\- symptomatic brain metastasis
- •\- contra\-indication for nuclear isolation
Outcomes
Primary Outcomes
Not specified
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