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Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
irinotecan hydrochloride
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult giant cell glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Safety
Activity in terms of progression-free survival

Secondary Outcome Measures

Full Information

First Posted
December 20, 2005
Last Updated
July 18, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00268359
Brief Title
Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
Official Title
Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult giant cell glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Safety
Title
Activity in terms of progression-free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J. Vredenburgh, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18981004
Citation
Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin Cancer Res. 2008 Nov 1;14(21):7068-73. doi: 10.1158/1078-0432.CCR-08-0260.
Results Reference
result
PubMed Identifier
18182667
Citation
Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated with bevacizumab and irinotecan. J Clin Oncol. 2008 Jan 10;26(2):271-8. doi: 10.1200/JCO.2007.13.3652.
Results Reference
result
PubMed Identifier
17317837
Citation
Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.
Results Reference
result

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Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

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