Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

July 18, 2014 updated by: Duke University

Bevacizumab in Combination With Irinotecan for Malignant Gliomas

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.

Study Overview

Status

Completed

Conditions

Brain and Central Nervous System Tumors

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Duke Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Activity in terms of progression-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: James J. Vredenburgh, MD, Duke Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Pro00004091
DUMC-6771-05-1R0
GENENTECH-AVF3311s
CDR0000450832 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.