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

• Research type

  Research Study

• Full title

  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

• IRAS ID

  82165

• Contact name

  Penelope Brock

• Sponsor organisation

  St. Anna Kinderkrebsforschung

• Eudract number

  2009-018077-31

• ISRCTN Number

  n.a

• Research summary

  High-risk neuroblastoma is the commonest extracranial solid tumour in children and accounts for 6-10% of all childhood cancers. Overall cure rates are low, and so effective new treatments are needed. Chimeric 14.18 anti-GD2 monoclonal antibody produced in Chinese hamster ovary cells (ch14.18/CHO) has already been tested in stage 4 neuroblastoma patients as a daily infusion in phase I/II clinical trials with encouraging results. Its feasibility to combine it with aldesleukin (IL-2) has been also demonstrated in patients with neuroblastoma. Aldesleukin (IL-2) is similar to a substance made by the body in all individuals to help white blood cells fight infection. There is evidence in the laboratory and in animals that aldesleukin increases the anti-cancer effect of monoclonal antibodies like ch14.18/CHO. This study aims to evaluate the safety and side effects experienced by patients receiving this combination of treatment, together with an additional drug already used in patients with neuroblastoma called isotretinoin. We also aim to see how the body responds to this combination of treatment and to determine a suitable dosing schedule for the antibody, so that this can be tested further in the future in Phase III studies. Patients will be eligible to participate if they have been diagnosed with neuroblastoma where the disease has reoccurred (relapsed) or is not responding to other forms of treatment (refractory). Patients must have a life expectancy of at least 12 weeks and other specific entry criteria apply. Patients will be assigned to 1 of 7 dose schedules depending on the experience of previous patients on the study, and receive 5 cycles of treatment. Each cycle could last 32-46 days. Patients will undergo several clinical assessments and tests throughout the study including scans, blood and bone marrow samples. The study aims to recruit 30-60 patients internationally (maximum 20 UK patients at 7 Hospital sites) in 18 months.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  12/WM/0079

• Date of REC Opinion

  3 May 2012

• REC opinion

  Further Information Favourable Opinion