onterm Infusion of anti-GD2 antibody ch14.18

• Conditions: High-risk neuroblastoma patients having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy fulfilling one of the following criteria:•Primary refractory patients with stage 4 disease with at least two lines of treatment prior to HDT/SCT, causing a delay from diagnosis to SCT of over 9 months •Relapse after primary stage 4 disease•Disseminated relapse after primary localized neuroblastoma; MedDRA version: 18.0Level: LLTClassification code 10029261Term: Neuroblastoma NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018077-31-DE
• Lead Sponsor: niversitätsmedizin Greifswald

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

Key inclusion criteria
Patients with neuroblastoma >1 and = 21 years of age (age limit for trial cohorts only), having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy to reduce tumour burden fulfilling one of the following criteria:
• Primary refractory patients with stage 4 disease with at least two lines of treatment prior to HDT/ASCT, causing a delay from diagnosis to ASCT of over 9 months. (For example, patients who are on the current high-risk SIOPEN trial (HR-NBL-1/SIOPEN) and have completed highdose treatment but are ineligible for the R2 randomization due to major
delays for toxicity).
• Relapse after primary stage 4 disease.
• Disseminated relapsed neuroblastoma having received ASCT.
Patients must have a life expectancy of at least 12 weeks.
Are the trial subjects under 18? yes
Number of subjects for this age range: 284
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria
Progressive disease and previous treatment with ch14.18/SP2/0 and/or ch14.18/CHO

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified