Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00268359
First received: December 20, 2005
Last updated: July 18, 2014
Last verified: February 2013
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268359

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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: July 18, 2014
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 July 22, 2014