Clinical trial · Interventional
Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Malignant Neoplasm to Brain | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- first level dose : 5 mg/kg Second level dose : 10 mg/kg Third level dose : 15 mg/kg
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- The Maximal Tolerated dose (MTD)
- timeFrame
- The MTD will be evaluated 6 weeks after the first administration ob bevacizumab
- description
- 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
Secondary outcomes (1)
- measure
- Tumor regression
- timeFrame
- The first evaluation will be performed 2 weeks after the first injection, 6 weeks after the end of radiotherapy and each 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLevy C, Allouache D, Lacroix J, Dugue AE, Supiot S, Campone M, Mahe M, Kichou S, Leheurteur M, Hanzen C, Dieras V, Kirova Y, Campana F, Le Rhun E, Gras L, Bachelot T, Sunyach MP, Hrab I, Geffrelot J, Gunzer K, Constans JM, Grellard JM, Clarisse B, Paoletti X. REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours. Ann Oncol. 2014 Dec;25(12):2351-2356. doi: 10.1093/annonc/mdu465. Epub 2014 Oct 1. PMID 25274615