Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma

May 22, 2017 updated by: Memorial Sloan Kettering Cancer Center

Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center @ Suffolk
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Genentech, Inc.
Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Philip Gutin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2005

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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