Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma

Completed · Phase 2

Conditions studied: Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Neoplasm

In brief

This randomized phase II trial is studying the side effects and how well giving bevacizumab together with irinotecan or temozolomide works in treating patients with recurrent or refractory glioblastoma multiforme or gliosarcoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with irinotecan or temozolomide may kill more tumor cells.

Key facts

Study ID

NCT00433381

Run by

National Cancer Institute (NCI)

People needed

123

Starts

2007-03-01

Expected to finish

2011-02-16

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma
• Original histology of low-grade glioma with subsequent histological diagnosis of GBM or gliosarcoma allowed
• Recurrent or refractory disease, meeting all of the following criteria:
• Must have received prior temozolomide
• Pathologic or imaging confirmation of tumor progression or regrowth required
• Confirmation of true progressive disease (rather than radiation necrosis) by positron emission tomography, thallium scanning, MRI spectroscopy, or surgical documentation required for patients who received prior interstitial brachytherapy, Gliadel wafer, or stereotactic radiosurgery
• Unequivocal radiographic evidence of tumor progression by MRI within the past 14 days (while on a stable dose of steroids for ? 5 days)
• No acute intratumoral hemorrhage on MRI
• Patients with MRI demonstrating old hemorrhage or subacute blood after a neurosurgical procedure (biopsy or resection) are eligible
• Karnofsky performance status 70-100%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 6 months after completion of bevacizumab therapy
• Systolic blood pressure ? 160 mm Hg or diastolic blood pressure ? 90 mm Hg (antihypertensive medication allowed)
• Able to undergo brain MRI scans with intravenous gadolinium
• Absolute neutrophil count ? 1,500 cells/mm?
• Platelet count ? 100,000 cells/mm?
• Hemoglobin ? 10 g/dL (transfusion or other intervention allowed)
• WBC ? 3,000 cells/mm?
• AST < 2 times upper limit of normal
• Bilirubin ? 1.6 mg/dL
• Creatinine < 1.5 mg/dL
• Urine protein:creatinine ratio ? 0.5 by urinalysis OR total urinary protein < 1,000 mg by 24-hour urine collection
• INR < 1.4 (for patients not on warfarin)
• No patients with severely impaired renal function (i.e., estimated glomerular filtration rate < 30 mL/min or on dialysis)

Where it is running

• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
• John Muir Medical Center-Walnut Creek — Walnut Creek, California, United States
• Yale University — New Haven, Connecticut, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Saint Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Saint Vincent Anderson Regional Hospital/Cancer Center — Anderson, Indiana, United States
• Franciscan Saint Francis Health-Beech Grove — Beech Grove, Indiana, United States
• IU Health Methodist Hospital — Indianapolis, Indiana, United States
• Reid Health — Richmond, Indiana, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Anne Arundel Medical Center — Annapolis, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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