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Bevacizumab in the Radiation Treatment of Recurrent 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: NCT00595322
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

This is a pilot study. The goal of this study is to test whether Bevacizumab is safe enough in patients with brain tumors so that a larger study can be conducted. This study will also give us some information about whether the combination of Bevacizumab and radiation has potential to become an effective treatment for regrowing brain tumors.

Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several different types of human cancer cells by blocking the effects of VEGF. There is also evidence that Bevacizumab enhances the effects of radiation on tumor cell


Condition or disease Intervention/treatment Phase
Brain Cancer Recurrent Malignant Gliomas Primary Brain Tumor Other: bevacizumab and radiation (IMRT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study
Actual Study Start Date : December 2005
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
bevacizumab and radiation (IMRT)
 Other: bevacizumab and radiation (IMRT)
bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT (30Gy) beginning anywhere from day 7-10 of cycle 2 (5 doses of 6 Gy over 2 and a half weeks)


Outcome Measures
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Primary Outcome Measures :
  1. To test the safety of bevacizumab in patients with recurrent malignant gliomas in preparation for a larger study to test the efficacy of this drug used during the initial radiation treatment of these tumors if safety is affirmed. [ Time Frame: conclusion of study ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Recurrent malignant glioma that has failed prior radiotherapy and/or chemotherapy. Surgery for the recurrence may be offered to selected patients prior to receiving bevacizumab and IMRT on this protocol.
  • MRI scan with gadolinium contrast showing geographically-circumscribed tumor < than or equal to 3.5cm. (Scan must be performed on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between date of imaging and registration, a new baseline MRI is required).
  • Patients must have recovered from the toxic effects of prior therapy:
  • An interval of > than or equal to 4 weeks (28 days) from prior cytotoxic therapy
  • An interval of > than or equal to 1 week (7 days) from any non-cytotoxic agents
  • An interval of > than or equal to 6 weeks (42 days) from the completion of radiation therapy
  • Absolute neutrophil count > than or equal to 1,500/mm3.
  • Platelet count > than or equal to 100,000/mm3.
  • Hemoglobin > than or equal to 10 g/dl.
  • BUN and serum creatinine both < 1.5 times upper limit of normal.
  • Total bilirubin both < 1.5 times upper limit of normal.
  • SGOT and SGPT both < than or equal to 3 times upper limit of normal.
  • Alkaline phosphatase < than or equal to 2 times upper limit of normal.
  • > than or equal to 18 years of age.
  • Karnofsky Performance Score > or equal to 70
  • Life expectancy > or equal to 12 weeks
  • Men and women with reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
  • Patient or their legal proxy must provide written informed consent prior to registration on study.

Exclusion Criteria:

  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
  • Blood pressure >150 mmHg systolic and/or >100 mmHg diastolic
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • Unstable angina within 12 months of study enrollment
  • CTC 3.0 Grade 2 or greater congestive heart failure
  • History of myocardial infarction within 12 months of study enrollment
  • History of stroke or transient ischemic attack at any time
  • Known CNS disease
  • Known hypersensitivity to any component of bevacizumab
  • History of peptic ulcer within the last 6 months
  • Clinically significant peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Use of ongoing anticoagulants or antiplatelet agents (aspirin, NSAIDS, etc)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of bevacizumab or anticipation of need for major surgical procedure during the course of the study. (Recently resected patients may be enrolled on-study two weeks post-surgery. However, treatment with Bevacizumab will not begin until 28 days after the surgical procedure for all patients.)
  • Craniotomy wound that has not sufficiently healed
  • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to study enrollment
  • Pregnant (positive pregnancy test) or lactating
  • Urine protein:creatinine ratio ≥1.0 at screening
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture
  • Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel, cavitation, or history of hemoptysis
  • Inability to comply with study and/or follow-up procedures
  • Glioma showing prior spontaneous hemorrhage as determined from the clinical history or from any preoperative CT or MRI scan.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00595322


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Genentech, Inc.
Investigators
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Principal Investigator: Philip Gutin, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00595322    
Other Study ID Numbers: 05-092
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Keywords provided by Memorial Sloan Kettering Cancer Center:
Bevacizumab
Radiation Treatment
Brain Cancer
Additional relevant MeSH terms:
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Glioma
Brain Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors