A PHASE I/II DOSE SCHEDULE FINDING STUDY OF CH14.18/CHO CONTINUOUS INFUSION COMBINED WITH SUBCUTANEOUS ALDESLEUKIN (IL-2) IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSED NEUROBLASTOMA A SIOPEN Study - Long term continuous infusion ch.14.18/CHO plus s.c IL2

• Conditions: Advanced refractory or relapsed neuroblatoma; MedDRA version: 14.1Level: PTClassification code 10066595Term: Neuroblastoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018077-31-IT
• Lead Sponsor: St. Anna Kinderkrebsforchung Children's Cancer Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 23 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Neuroblastoma patients with> 1 and = 21 years, we have received at least one prior treatment with high doses followed by reinfusion of hematopoietic stem cells after conventional therapy to reduce tumor burden and meet any of the following criteria: • Refractory Neuroblastoma stage 4 with at least 2 lines of treatment before further doses resulting in an interval between diagnosis and transplantation of more than 9 months. Relapse res.in stage 4 • responsive metastatic recurrence after diagnosis of localized neuroblastoma
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Progressive disease and / or previous treatment with ch.14.18/SP2/0 and / or ch14.18CHO

Study & Design

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