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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352521
• Other study ID #: Pro00012387
• Secondary ID: DUMC-8053-05-12R
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2006
• Last updated: July 18, 2014
• Start date: April 2006
• Est. completion date: July 2009

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• bevacizumab

• irinotecan

Procedure:
• dynamic contrast-enhanced magnetic resonance imaging

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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