ong term continuous infusion ch14.18/CHO plus s.c. aldesleukin (IL-2)

Phase 1

• 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; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018077-31-PL
• Lead Sponsor: Jagiellonian University Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• 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 high-dose treatment but are ineligible for the R4 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 284
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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