Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis

Sponsor
Centre Francois Baclesse
Study ID
NCT01332929
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Malignant Neoplasm to Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 11, 2011
Start date
Jun 30, 2010
Status verified
Sep 2013
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    first level dose : 5 mg/kg Second level dose : 10 mg/kg Third level dose : 15 mg/kg

Primary Outcome Measure

The Maximal Tolerated dose (MTD) [ Time Frame: The MTD will be evaluated 6 weeks after the first administration ob bevacizumab ]

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