Safety of Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility 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/mm
- •Platelet count \> than or equal to 100,000/mm
- •Hemoglobin \> than or equal to 10 g/dl.
- •BUN and serum creatinine both \< 1.5 times upper limit of normal.
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
Outcomes
Primary Outcomes
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