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

Phase 2

Completed

• Conditions: neuroblastoma in children; 10072990

• Registration Number: NL-OMON39557
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- relapsed or progressive neuroblastoma
- age 1 up to 18 years
- measurable or evaluable disease
- evidence of sufficient MIBG uptake in bone or soft tissue
-lansky play score > 70 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

Exclusion Criteria

-other anti-tumour therapy
- symptomatic brain metastasis
- contra-indication for nuclear isolation
- hypersensitivity to gemcitabine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the objective response rate of the combination of gemcitabine and<br /><br>131I-MIBG (MIBG-gem) in children with relapsed or progressive neuroblastoma.<br /><br>Response rate will be assessed per stratum: MIBG pretreated and MIBG-naieve.<br /><br>The duration of response, time to progression and survival will be assessed.<br /><br>To characterise safety and toxicity profile of this combination treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>