Clinical trial NCT00352521: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma
Official title: Dynamic Contrast-Enhanced Magnetic Resonance Imaging With Bevacizumab in Combination With Irinotecan for Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival and Tumor Response
timeFrame: 2 years
measure: Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage
timeFrame: 2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: James J. Vredenburgh, MD
role: STUDY_CHAIR
References: