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MRI in Patients Receiving Bevacizumab and Irinotecan for Recurrent Malignant Glioma
This study is ongoing, but not recruiting participants.
First Received: July 13, 2006   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: NCT00352521
  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 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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: bevacizumab
Drug: irinotecan hydrochloride
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Phase II

MedlinePlus related topics: Cancer MRI Scans
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas

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

Primary Outcome Measures:
  • Tumor vascular permeability and blood flow [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reproducibility of dynamic contrast-enhanced (DCE)-MRI [ Designated as safety issue: No ]
  • Predictive value of DCE-MRI [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2006
Detailed Description:

OBJECTIVES:

Primary

  • Examine the effect of bevacizumab and irinotecan hydrochloride on tumor vascular permeability and blood flow in patients with recurrent malignant gliomas.

Secondary

  • Determine the reproducibility of dynamic contrast-enhanced (DCE)-MRI in these patients.
  • Determine the predictive value of DCE-MRI in patients treated with bevacizumab and irinotecan hydrochloride.
  • Describe the activity of this regimen, as measured by response rate and progression-free survival, in these patients.
  • Describe the toxicity associated with this regimen.

OUTLINE: Patients receive bevacizumab IV and irinotecan IV 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.

PROJECTED ACCRUAL: A total of 20 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352521

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:
No publications provided

Study ID Numbers: CDR0000481476, DUMC-8053-05-12R0
Study First Received: July 13, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00352521     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Irinotecan
Bevacizumab
Central Nervous System Neoplasms
Angiogenesis Inhibitors
Camptothecin
Ependymoma
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Bevacizumab
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Glioma
Angiogenesis Modulating Agents
Nervous System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Nervous System Diseases
Enzyme Inhibitors
Angiogenesis Inhibitors
Camptothecin
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Neoplasms, Neuroepithelial
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009