Back to resultsBevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Primary Purpose
Brain Cancer, Malignant Glioma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiotherapy (RT) in combination with temozolomide and bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Brain Cancer focused on measuring Radiation, BEVACIZUMAB, AVASTIN, TEMOZOLOMIDE, newly diagnosed, Glioblastoma, GBM, malignant glioma, Radiotherapy, 08-126
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 < 2.5X upper limit of normal (ULN)
- Serum creatinine < 2X ULN
- Bilirubin < 2X ULN
- All patients must sign written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Memoral Sloan Kettering Cancer Center
- Memorial Sloan-Kettering Cancer Center at Commack
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RT, with temozolomide and bevacizumab
Arm Description
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
Secondary Outcome Measures
Progression Free Survival
Neurocognitive Outcome
Full Information
NCT ID
NCT00782756
First Posted
October 29, 2008
Last Updated
January 10, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Genentech, Inc., National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00782756
Brief Title
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Official Title
A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2008 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Genentech, Inc., National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Malignant Glioma
Keywords
Radiation, BEVACIZUMAB, AVASTIN, TEMOZOLOMIDE, newly diagnosed, Glioblastoma, GBM, malignant glioma, Radiotherapy, 08-126
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RT, with temozolomide and bevacizumab
Arm Type
Experimental
Arm Description
This treatment regimen is novel in that it delivers the initial course of RT over 2 weeks instead of 6 weeks; also, the addition of bevacizumab during and after RT is a new approach.
Intervention Type
Other
Intervention Name(s)
radiotherapy (RT) in combination with temozolomide and bevacizumab
Intervention Description
Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.
Post RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles.
Follow up: CBC weekly, comprehensive panel and urinalysis monthly, blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive testing (approximately 4months post RT, 1 year after diagnosis and then annually in long term survivors). Blood sample for correlative studies monthly.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
through study completion, an average of 1 year
Title
Neurocognitive Outcome
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 2.5X upper limit of normal (ULN)
Serum creatinine < 2X ULN
Bilirubin < 2X ULN
All patients must sign written informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Omuro, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memoral Sloan Kettering Cancer Center
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
We'll reach out to this number within 24 hrs