A phase II study of the combination of gemcitabine with 131I-MIBG therapy for children with neuroblastoma without other treatment options.

Phase II trial of the combination of gemcitabine and 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma - MIBG-Gem

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007974-45-NL

Enrollment

Registered

2008-12-29

Start date

2009-07-16

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed or progressive neuroblastoma in pediatric patients of 1 to 18 years

Interventions

Product Name: gemcitabine Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: GEMCITABINE HYDROCHLORIDE CAS Number: 122111-03-9 INN or Proposed INN: GEMCITABINE CAS Number: 9505

Eligibility

Sex/Gender

All

Inclusion 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 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

Exclusion criteria: -other anti-tumour therapy - symptomatic brain metastasis - contra-indication for nuclear isolation

Design outcomes

Primary

Measure	Time frame
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. The duration of response, time to progression and survival will be assessed. ;Timepoint(s) of evaluation of this end point: After (every) 2 cycles of study treatment response will be evaluated	—

Measure

Time frame

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. The duration of response, time to progression and survival will be assessed. ;Timepoint(s) of evaluation of this end point: After (every) 2 cycles of study treatment response will be evaluated

—

Secondary

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

Countries

Germany, Netherlands

Contacts

Public ContactHuib Caron

AMC

h.n.caron@amc.uva.nl+31205663050

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026