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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse
• Collaborators: Institut Curie; National Cancer Institute, France; Roche Pharma AG
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 18 < age < 70 man or woman

• Patient with a cytologically or histologically proven primary solid tumor

• With measurable and inoperable brain metastasis,

• Without meningeal carcinomatosis ,

• ECOG performance status ≤ 2,

• No previous treatment with angiogenesis inhibitors less than 3 months before inclusion,

• No chemotherapy and/or immunotherapy less than 3 weeks before treatment,

• No contra-indication to bevacizumab,

• No proteinuria with urine dipstick for proteinuria > 2+

• Blood sample ≤ 7 days before inclusion:

• Hemoglobin ≥ 10 G/100 ml

• Neutrophils count ≥ 1500 /mm3

• Platelets ≥ 100 000 /mm3

• Normal coagulation test: INR ≤ 1,5 ET TCA ≤ 1,5 x LSN 7 days before inclusion

• A written informed consent must be obtained.

Exclusion Criteria:

• Haemorrhagic brain metastasis,

• Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg). Patients with high initial blood pressure are eligible if entry criteria are met after initiation or adjustment of antihypertensive medication,

• Prior brain radiation therapy

• Concomitant anticoagulant treatment

• Significant surgical procedure less than 28 days before inclusion (1 day if minor surgical act)

• Significant cardio-vascular disease, eg:

• Cerebral vascular thrombosis/haemorrhage or myocardial infarction <6 months

• Congestive heart failure > 2 NYHA

• Uncontrolled coronary disease

• Prior venous and/or arterial thrombosis < 6 months before inclusion

• Severe concurrent uncontrolled medical disease,

• Any psychiatric disorder that might prevent the subject from completing the treatment or interfere with the interpretation of the study results,

• Pregnancy or breast feeding

• Individual deprived of liberty or placed under the authority of a tutor.