Full Text View
Tabular View
No Study Results Posted
Related Studies
Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas
This study is ongoing, but not recruiting participants.
First Received: December 20, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00268359
  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 II

MedlinePlus related topics: Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Bevacizumab in Combination With Irinotecan for Malignant Gliomas

Further study details as provided by National Cancer Institute (NCI):

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
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
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 University
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000450832, DUMC-6771-05-1R0, GENENTECH-AVF3311s
Study First Received: December 20, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00268359     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult gliosarcoma
recurrent adult brain tumor
adult giant cell glioblastoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Irinotecan
Central Nervous System Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Recurrence
Camptothecin
Brain Neoplasms
Oligodendroglioma
Glioma
Gliosarcoma
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Irinotecan
Enzyme Inhibitors
Central Nervous System Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Camptothecin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009