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Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
irinotecan
dynamic contrast-enhanced magnetic resonance imaging
Sponsored by
Duke University
About
Eligibility
Locations
Arms
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 mixed glioma, adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult glioblastoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult pineal gland astrocytoma

Eligibility Criteria

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

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab and irinotecan

Arm Description

The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.

Outcomes

Primary Outcome Measures

Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
Assessed by DCE-MRI

Secondary Outcome Measures

Overall Survival and Tumor Response
Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage

Full Information

First Posted
July 13, 2006
Last Updated
July 18, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00352521
Brief Title
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Official Title
Dynamic Contrast-Enhanced Magnetic Resonance Imaging With 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
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

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 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.
Detailed Description
OBJECTIVES: Primary Examine the effect of bevacizumab and irinotecan on vascular permeability and blood flow in patients with recurrent malignant gliomas. Secondary Determine the reproducibility of dynamic contrast-enhanced (DCE-MRI) in malignant gliomas. Determine the predictive value of DCE-MRI in patients with recurrent malignant gliomas treated with bevacizumab and irinotecan. Describe the activity of the combination of bevacizumab with irinotecan as measured by response rate and progression-free survival. Describe the toxicity associated with the administration of bevacizumab with irinotecan. OUTLINE: Patients receive bevacizumab IV on days 1, 15, and 29 and irinotecan IV on days 2, 15, and 29 during the first 6-week cycle. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo dynamic contrast-enhanced MRI 4 times.

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 mixed glioma, adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult glioblastoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult pineal gland astrocytoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab and irinotecan
Arm Type
Experimental
Arm Description
The bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Type
Drug
Intervention Name(s)
irinotecan
Other Intervention Name(s)
Camptosar
Intervention Type
Procedure
Intervention Name(s)
dynamic contrast-enhanced magnetic resonance imaging
Primary Outcome Measure Information:
Title
Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
Description
Assessed by DCE-MRI
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Survival and Tumor Response
Time Frame
2 years
Title
Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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

Learn more about this trial

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

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