Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Genentech, Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00595322
First received: January 7, 2008
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Brain Cancer
Recurrent Malignant Gliomas
Primary Brain Tumor
Other: bevacizumab and radiation (IMRT)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: December 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595322

Locations
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
Principal Investigator: Philip Gutin, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00595322     History of Changes
Other Study ID Numbers: 05-092
Study First Received: January 7, 2008
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Bevacizumab
Radiation Treatment
Brain Cancer

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014