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

Recruiting
Conditions
neuroblastoma, children, relapsed, progressive
Registration Number
NL-OMON24917
Lead Sponsor
Academisch Medisch Centrum Amsterdam
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
66
Inclusion Criteria

1. Histological proven neuroblastoma;

2. Measurable primary and/or metastatic disease;

Exclusion Criteria

1. Received treatment within the last 21 days with an
investigational or conventional anti-cancer drug;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Determination of efficacy as measured by response rate (and time-to-event measurements).
Secondary Outcome Measures
NameTimeMethod
Characterization of safety and toxicity profile.
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