VIT-0910
Research type
Research Study
Full title
INTERNATIONAL RANDOMIZED PHASE II TRIAL OF THE COMBINATION OF VINCRISTINE AND IRINOTECAN WITH OR WITHOUT TEMOZOLOMIDE (VI OR VIT) IN CHILDREN AND ADULTS WITH REFRACTORY OR RELAPSED RHABDOMYOSARCOMA
IRAS ID
77320
Contact name
Julia Chisholm
Sponsor organisation
Centre Oscar Lambret
Eudract number
2010-023135-42
Clinicaltrials.gov Identifier
Research summary
Rhabdomyosarcoma is the commonest soft tissue sarcoma in children and occurs throughout adult life. While many patients with localised rhabdomyosarcoma do well, outcomes remain poor in metastatic and refractory disease and new treatment strategies are urgently needed.The combination of chemotherapy agent irinotecan with vincristine has been shown to be beneficial in rhabdomyosarcoma but at present irinotecan is not routinely used in first-line therapy in Europe. Temozolomide potentiates the action of irinotecan and is commonly used with irinotecan for the treatment of other tumours. We wish to investigate its role in Rhabdomyosarcoma. The main aim of this trial is to evaluate how well the combination of temozolomide with vincristine and irinotecan (VIT) works in children and adult patients with refractory or relapsed rhabdomyosarcoma as assessed by tumour response. It also aims to evaluate the safety and tolerability of all three drugs in combination vs vincristine with irinotecan (VI) alone. In this trial 80 patients aged between 6 months to 50 years with relapsed or refractory Rhabdomyosarcoma who have failed standard treatment, will be randomised to receive vincristine 1.5 mg/m2 iv on Days 1 and 8, irinotecan 50 mg/m2 iv on Days 1-5 with or without oral temozolomide 125 mg/m2 on Days 1-5 of each 21 day cycle. The temozolomide dose will be increased to 150mg/m2 in subsequent cycles provided patients do not experience severe side effects. Tumour response will be assessed by CT or MRI scans after the second cycle of treatment and after every 2 subsequent cycles. It is anticipated that patients will receive 12 cycles of treatment in total if it is proving beneficial. This study will show whether the VIT combination is sufficiently active to take forward for further larger scale trials in patients with Rhabdomyosarcoma and may lead to changes in clinical practise.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
11/SC/0410
Date of REC Opinion
18 Jan 2012
REC opinion
Further Information Favourable Opinion