Status:
COMPLETED
Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Genentech, Inc.
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: 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...
Detailed Description
OBJECTIVES: Primary * To determine the 6-month progression-free survival of patients with relapsed or progressive high-grade gliomas treated with bevacizumab and carmustine. Secondary * To evaluat...
Eligibility Criteria
Inclusion
- Histologically confirmed GBM, anaplastic astrocytoma, anaplastic oligoastrocytoma or anaplastic oligodendroglioma.
- Disease progression (confirmed by MRI, PET or both) after radiation therapy
- At least 28 days have elapsed since chemotherapy, major surgery or radiation therapy.
- No other malignancy within 3 years except for non-melanomatous skin cancer or in situ cervical cancer.
- Karnofsky performance score at least 70
- Platelet count ≥ 130/mm3.
- Absolute neutrophil count ≥ 1500/mm3
- Calculated creatinine clearance greater than 45 mg/dl
- AST \< 2 times the upper limit of normal
- Bilirubin \< 1.5 times the upper limit of normal
- Ability to give signed informed consent
- Patients must be 18 years of age or older.
Exclusion
- Prior intravenous or oral nitrosoureas (BCNU, CCNU) or prior VEGF targeted therapy including bevacizumab. No more than two prior chemotherapy regimens are allowed. Prior or current steroid use is allowed.
- Evidence of CNS hemorrhage
- Requirement for therapeutic anticoagulation
- Any grade 3 or greater hemorrhage within the previous 28 days
- Active inflammatory bowel disease
- Inadequately controlled hypertension
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Significant vascular disease
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- 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
- Proteinuria at screening
- Pregnant (or lactating). Use of effective means of contraception in subjects of child-bearing potential
- Prior organ transplantation
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- Known acquired immune deficiency syndrome (AIDS) or HIV positive status
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00795665
Start Date
June 1 2008
End Date
December 1 2015
Last Update
May 12 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis Cancer Center
Sacramento, California, United States, 95817