Brain and Central Nervous System Tumors Clinical Trial
Official title:
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Verified date | February 2013 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 carry tumor-killing substances to them. Bevacizumab may also block blood
flow to the tumor. Drugs used in chemotherapy, such as irinotecan, 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 may kill more tumor cells. Diagnostic
procedures, such as MRI, may help doctors predict a patient's response to treatment and help
plan the best treatment.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with
irinotecan works in treating patients with recurrent malignant glioma and how well MRI
predicts response to treatment.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2009 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of any of the following malignant gliomas: - Glioblastoma multiforme - Anaplastic astrocytoma - Grade 3 or greater WHO astrocytic, oligodendroglial, or mixed glial tumors that were initially diagnosed by histologic examination of a tumor specimen obtained from biopsy or resection - Recurrent disease - No more than 3 prior recurrences - Measurable recurrent or residual primary CNS neoplasm on contrast-enhanced MRI or CT scan - No evidence of CNS hemorrhage on baseline MRI or CT scan PATIENT CHARACTERISTICS: - Karnofsky performance status 60-100% - Hematocrit > 29% - Absolute neutrophil count > 1,500/mm³ - Platelet count > 125,000/mm³ - Creatinine < 1.5 mg/dL - SGOT < 1.5 times upper limit of normal (ULN) - Bilirubin < 1.5 times ULN - Not pregnant or nursing - Fertile patients must use effective contraception - No active infection - No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: - At least 6 weeks since prior surgical resection - More than 28 days since prior major surgical procedure or open biopsy - More than 7 days since prior minor surgical procedure, fine-needle aspirations, or core biopsies - At least 6 weeks since prior chemotherapy* - At least 4 weeks since prior radiotherapy* - No concurrent immunosuppressive agents - No concurrent therapeutic anticoagulation - Concurrent corticosteroids allowed if dose has been stable for 1 week prior to study entry NOTE: * Unless there is unequivocal evidence of progressive disease |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS) | Assessed by DCE-MRI | 1 year | No |
Secondary | Overall Survival and Tumor Response | 2 years | No | |
Secondary | Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage | 2 years | Yes |
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