Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis
|ClinicalTrials.gov Identifier: NCT01332929|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : September 12, 2013
This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and whole brain radiation therapy for the treatment of patients with brain metastasis of solid tumors. If this therapeutic scheme confirms it's safety profile, the investigators can expect:
- first, to allow that all patients can receive bevacizumab for their advanced and/or metastatic cancer if necessary, even in case of brain metastasis.
- Secondly, if this trial confirm a synergic effect of the combination of angiogenesis inhibitors and brain radiotherapy for local control of brain metastasis, an improvement of the therapeutic results for these patients which have a poor hope of survival and for which none innovative approach is currently suggested.
Moreover, the investigators hope that the analysis of the different data of MRI evaluation - morphological and functional - will allow better definition of radiological evaluation of the therapeutic effect of angiogenesis inhibitors on brain metastasis.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm to Brain||Drug: Bevacizumab||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
first level dose : 5 mg/kg Second level dose : 10 mg/kg Third level dose : 15 mg/kg
5, 10 or 15 mg/kg, IV, on day 1, 15 and 29 plus radiation therapy of the whole brain.
For level 0,1 and 2, a total dose of 30 Gy will be administered in 15 fractions of 2 Gy, from D15 to D33 with 5 fractions a week.
For level 3,a total dose of 30 Gy will be administered in 10 fractions of 3 Gy, from D15 to D26 with 5 fractions a week.
- The Maximal Tolerated dose (MTD) [ Time Frame: The MTD will be evaluated 6 weeks after the first administration ob bevacizumab ]The primary objective is to determine the Maximal Tolerated Dose (MTD) of the combination of bevacizumab and whole brain radiation therapy for patients with brain metastases
- Tumor regression [ Time Frame: The first evaluation will be performed 2 weeks after the first injection, 6 weeks after the end of radiotherapy and each 3 months ]The secondary objective is to assess the treatment-related parameters of tumor regression by a morphologic and functional MRI six weeks after the end of the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332929
|Centre François Baclesse|
|Caen, France, 14076|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Léon Bérard|
|Lyon, France, 69373|
|Paris, France, 75248|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre René Gauducheau|
|St Herblain, France, 44805|
|Principal Investigator:||Christelle LEVY, MD||Centre François Baclesse|