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A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

Phase 2
18 Years
Open (Enrolling)
Brain Cancer, Malignant Glioma

Thank you

Trial Information

A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To test the safety and efficacy of bevacizumab and temozolomide in combination with hypo-fractionated radiotherapy inpatients with newly diagnosed glioblastoma in terms of improvements in overall survival.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Antonio Omuro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Brain Cancer
  • Malignant Glioma
  • Radiation
  • newly diagnosed
  • Glioblastoma
  • GBM
  • malignant glioma
  • Radiotherapy
  • 08-126
  • Brain Neoplasms
  • Glioma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Commack Commack, New York  11725
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey