Phase II trial of the addition of gemcitabine to 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma

Conditions: relapsed or progressive neuroblastoma in pediatric patients of 1 to 18 years
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2007-007974-45-DE

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

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
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

Exclusion Criteria

- 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
Main Objective: To evaluate the efficacy and toxicity of gemcitabine in combination with 131I-MIBG in pediatric patients with relapsed or progressive neuroblastoma. ;Secondary Objective: to evaluate the safety and toxicity profile of the addition of gemcitabine to 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma.;Primary end point(s): To assess the objective response rate of the combination of gemcitabine and 131I-MIBG (MIBG-gem) in children with relapsed or progressive neuroblastoma. Response rate will be assessed per stratum: MIBG pretreated and MIBG-naive.<br>The duration of response, time to progression and survival will be assessed.<br>;Timepoint(s) of evaluation of this end point: After (every) 2 cycles of study treatment response will be evaluated<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To characterise safety and toxicity profile of this combination treatment. ;Timepoint(s) of evaluation of this end point: Safety analysis after the first cycle and throughout the study