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

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-IE
• Lead Sponsor: St. Anna Kinderkrebsforschung/CCRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-11
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 444

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 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.

Patients who received previus treatments with ch14.18 SP2/0 or ch14.18/CHO are eligible if they test negative for human anti-chimeric antibodies (HACA) at screening.

Patients who are platelet transfusion dependent are eligible if they adequately respond to platelet transfusion (>20.000/µl)

Patients who take topical and local acting immunosuppressive drugs without relevant systemic activity such as cremes, inhalative and immunosuppressive drugs acting on mucoasal membranes are allowed on the trial.

A substitute test for patients who can not perform a pulmonary function test was defined in order to assess pulmonary function prior to immunotherapy: Pulse oximetry at room air. Patients with a reading = 94% are eligible.

Are the trial subjects under 18? yes
Number of subjects for this age range: 444
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
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