Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
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Purpose
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 stop the growth of tumor cells by blocking 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 tumors cells.
PURPOSE: This phase II trial is studying the side effects of bevacizumab and how well giving bevacizumab together with irinotecan works in treating patients with recurrent or refractory gliomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: bevacizumab Drug: irinotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bevacizumab in Combination With Irinotecan for Malignant Gliomas |
- Safety [ Designated as safety issue: Yes ]
- Activity in terms of progression-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | May 2005 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the safety of bevacizumab and irinotecan hydrochloride in patients with recurrent or refractory grade 3 or 4 malignant gliomas.
Secondary
- Determine the activity of this regimen, in terms of progression-free survival, in these patients.
OUTLINE: Patients receive bevacizumab and irinotecan hydrochloride every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary grade 3 or 4 malignant glioma of 1 of the following types:
- Glioblastoma multiforme
- Gliosarcoma
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Patients with recurrent disease whose original diagnostic pathology confirmed malignant glioma will not need re-biopsy
- Measurable recurrent or residual primary disease on contrast-enhanced MRI or CT scan
- Failed ≥ 1 prior chemotherapy regimen (with or without radiotherapy)
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hematocrit > 29%
- Absolute neutrophil count > 1,500/mm^3
- Platelets > 125,000/mm^3
- Serum SGOT and bilirubin < 1.5 times upper limit of normal
- Creatinine < 1.5 mg/dL
- Urine protein:creatinine ratio ≤ 1.0
- Blood pressure ≤ 150/100 mmHg
- No unstable angina
- No New York Heart Association class II or greater congestive heart failure
- No myocardial infarction within the past 6 months
- No stroke within the past 6 months
- No clinically significant peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- At least 4 weeks must have elapsed since prior chemotherapy or radiotherapy unless there is unequivocal evidence of tumor progression
- At least 6 weeks since prior surgical resection
- No previous major surgical procedures or open biopsies within 28 days prior to study entry
- No previous minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to study entry
- No anticipated need for major surgical procedures during the course of the study
- No concurrent aspirin, non-steroidal anti-inflammatory drugs, or clopidogrel
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | James J. Vredenburgh, MD | Duke Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00268359 History of Changes |
| Other Study ID Numbers: | Pro00004091, DUMC-6771-05-1R0, GENENTECH-AVF3311s, CDR0000450832 |
| Study First Received: | December 20, 2005 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Duke University:
|
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma |
adult gliosarcoma recurrent adult brain tumor adult giant cell glioblastoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases Irinotecan Camptothecin Bevacizumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013