Bevacizumab and standard chemotherapy in childhood soft−tissue sarcoma

• Research type

  Research Study

• Full title

  Open-label, multi-center, randomized, phase II study evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.

• IRAS ID

  20504

• Contact name

  Julia C Chisholm

• Eudract number

  2007−005017−19

• Clinicaltrials.gov Identifier

  NCT00643565

• Research summary

  This study is being conducted by F Hoffmann La-Roche Ltd. to determine whether Avastin can be used to improve the effectiveness of treatment for children and adolescents with rhabdomyosarcoma (RMS) or non-rhabdomyosarcoma (NRSTS) that has metastasized.Despite advances in the treatment of these tumors in children, including combined chemotherapy, radiotherapy and/or surgery, their prognosis is poor, and there is a need for new therapeutic agents. Avastin, which inhibits development of tumor blood supply, improves efficacy when administered with chemotherapy in some cancers in adults, including colon, rectum, breast, and lung; it is therefore important to assess the effectiveness of Avastin in childhood cancers which are difficult to treat. Although Avastin has been approved by Health Authorities for treatment of some cancers, it has not been approved for treatment of RMS or NRSTS; and its use in this study is experimental.The study is expected to take 9.5 years; 150 children and adolescents under the age of 18, with metastatic RMS or NRSTS, will be treated in up to 50 hospitals in Europe. Patients will receive either chemotherapy and Avastin, or chemotherapy alone, over a period of 18 months; Avastin will be given every three weeks during a 27 week ??induction? period, during which radiotherapy and/or surgery may also be used, and then every two weeks during a twelve month ??maintenance? period, After the treatment period patients will be followed with regular hospital visits for up to eight years.In addition to a possible advance in treatment of RMS and NRSTS, this study will provide information regarding the safety, tolerability and long term effects of Avastin in children, and the way Avastin is broken down and eliminated from the body in childhood.

• REC name

  London - Central Research Ethics Committee

• REC reference

  09/H0718/18

• Date of REC Opinion

  19 Jun 2009

• REC opinion

  Further Information Favourable Opinion