Status:
COMPLETED
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Genentech, Inc.
National Institutes of Health (NIH)
Conditions:
Brain Cancer
Malignant Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 chem...
Eligibility Criteria
Inclusion
- 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 \< 2.5X upper limit of normal (ULN)
- Serum creatinine \< 2X ULN
- Bilirubin \< 2X ULN
- All patients must sign written informed consent
Exclusion
- Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
- Any prior experimental therapy for glioma.
- Multicentric glioma
- Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
- Serious medical or psychiatric illness that would in the opinion of the investigator interfere with the prescribed treatment.
- Pregnant or breast feeding women.
- Refusal to use effective contraception
- Inadequately controlled hypertension (defined as systolic blood pressure \>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
Key Trial Info
Start Date :
October 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00782756
Start Date
October 28 2008
End Date
March 23 2017
Last Update
February 6 2018
Active Locations (3)
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1
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065