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Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00782756
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Collaborators:
Genentech, Inc.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE October 29, 2008
First Posted Date  ICMJE October 31, 2008
Results First Submitted Date  ICMJE December 13, 2017
Results First Posted Date  ICMJE February 6, 2018
Last Update Posted Date February 6, 2018
Actual Study Start Date  ICMJE October 28, 2008
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2008)
To test the safety and feasibility of delivering bevacizumab and temozolomide in combination with hypo-fractionated radiotherapy to patients with newly diagnosed glioblastoma [ Time Frame: conclusion of the study ]
Change History Complete list of historical versions of study NCT00782756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2008)
  • Progression Free Survival [ Time Frame: conclusion of the study ]
  • Overall survival [ Time Frame: conclusion of the study ]
  • Neurocognitive Outcome [ Time Frame: conclusion of the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
Official Title  ICMJE A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Cancer
  • Malignant Glioma
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Other: radiotherapy (RT) in combination with temozolomide and bevacizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2008)
49
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00782756
Other Study ID Numbers  ICMJE 08-126
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Genentech, Inc.
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Antonio Omuro, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP