Phase 2
Completed N=40
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Source: ClinicalTrials.gov NCT00782756 ↗Enrolled (actual)
40
Serious AEs
47.5%
Results posted
Feb 2018
Primary outcomePrimary: Number of Participants With Adverse Events — 40 Participants
Summary
The purpose of this study is to test the safety of a new plan for treating glioblastoma. The usual first treatment for glioblastoma is to give focused radiation over 6 weeks in combination with a chemotherapy called temozolomide. In this study the radiation will be given over 2 weeks in combination with temozolomide and another drug, bevacizumab, will also be given. Our idea is that this treatment plan may attack both the tumor and the blood vessels feeding the tumor more effectively. This study will look at what effects, good or bad, this approach has on the patient and the tumor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
40 | — |
| SECONDARY Progression Free Survival |
10 | — |
| SECONDARY Neurocognitive Outcome |
37; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologic diagnosis of glioblastoma or grade IV glioma.
- Tumor volume should be less than 60 cc (approximately 5cm maximum diameter).
- Age > or = to 18
- KPS ≥70
- Granulocyte count >1.5 X 10 9/L
- Platelet count >99 X 10 9/L
- SGOT 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 12 months prior to Day 1
- History of stroke or transient ischemic attack
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria as demonstrated by a UPC ratio ≥ 1.0 at screening
- Known hypersensitivity to any component of bevacizumab
Data sourced from ClinicalTrials.gov (NCT00782756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.