Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
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ClinicalTrials.gov Identifier: NCT00782756 |
Recruitment Status :
Completed
First Posted : October 31, 2008
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Brain Cancer Malignant Glioma | Other: radiotherapy (RT) in combination with temozolomide and bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma |
Actual Study Start Date : | October 28, 2008 |
Actual Primary Completion Date : | March 23, 2017 |
Actual Study Completion Date : | March 23, 2017 |

Arm | Intervention/treatment |
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Experimental: RT, with temozolomide and bevacizumab
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.
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Other: radiotherapy (RT) in combination with temozolomide and bevacizumab
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. |
- Number of Participants With Adverse Events [ Time Frame: through study completion, an average of 1 year ]Safety assessments and toxicity grading will follow CTCAE Version 4 Grade
- Progression Free Survival [ Time Frame: through study completion, an average of 1 year ]
- Neurocognitive Outcome [ Time Frame: through study completion, an average of 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782756
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center | |
Basking Ridge, New Jersey, United States | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center at Commack | |
Commack, New York, United States, 11725 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Antonio Omuro, MD | Memorial Sloan Kettering Cancer Center |
Documents provided by Memorial Sloan Kettering Cancer Center:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00782756 |
Other Study ID Numbers: |
08-126 |
First Posted: | October 31, 2008 Key Record Dates |
Results First Posted: | February 6, 2018 |
Last Update Posted: | February 6, 2018 |
Last Verified: | March 2017 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Radiation BEVACIZUMAB AVASTIN TEMOZOLOMIDE newly diagnosed |
Glioblastoma GBM malignant glioma Radiotherapy 08-126 |
Glioma Brain Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Bevacizumab Temozolomide Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |