Clinical Trials Search
Clinical Trial 19433
Interventions:Avastin (Bevacizumab); Bevacizumab; Dexamethasone; Placebo; prednisone
Study Type: Treatment
Phase of Study: Phase II
- Sepideh Mokhtari
Randomized Phase II Study: Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BeSt) for Radionecrosis after Radiosurgery for Brain Metastases
The purpose of this study is test whether adding a drug called bevacizumab to standard corticosteroid therapy will improve the participant's symptoms over corticosteroid therapy alone by improving the radionecrosis and minimizing treatment-related side effects. The effects of bevacizumab with standard corticosteroid therapy will be compared to a placebo with standard corticosteroid therapy.
2.0 OBJECTIVES 2.1 Primary Objective: To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy. 2.2 Secondary Objectives: 2.2.1 To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy. 2.2.2 To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms. 2.2.3 To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms. 2.2.4 To compare the dose and duration of corticosteroids required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores. 2.3 Correlative Objectives: 2.3.1 To explore serum/urine biomarkers that predict for treatment response. 2.3.2 To explore early imaging biomarkers that predict for treatment response.