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Brain and Central Nervous System TumorsPhase 2NCT00352521

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) With Bevacizumab and Irinotecan for Malignant Glioma

A Phase 2 study testing bevacizumab, irinotecan and dynamic contrast-enhanced magnetic resonance imaging in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
bevacizumab, irinotecan and dynamic contrast-enhanced magnetic resonance imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Apr 2006to Jul 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Dynamic Contrast-Enhanced Magnetic Resonance Imaging With 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 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.

Read the 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.

Being tested
bevacizumab, irinotecan, dynamic contrast-enhanced magnetic resonance imaging
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
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Glioma, Glioblastoma, Gliosarcoma, Brain Neoplasms, Ependymoma, Oligodendroglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Also called Avastin

  • irinotecanDrug

    Also called Camptosar

  • dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery

Study groups in NCT00352521
Study groupRoleWhat they receive
Bevacizumab and irinotecanExperimentalThe bevacizumab will be dosed at 10 mg/kg every 14 days (days 1, 15 and 29) and the irinotecan on days 2, 15, and 29 of the first six week schedule. The irinotecan dose will depend on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). If the patient is on an EIAED, the patient will receive 340 mg/m2 on days 2, 15, and 29 of the first six week schedule. If the patient is not on an EIAED, the dose of irinotecan will be 125 mg/m2 on days 2, 15, and 29 of the first six week schedule. After the first cycle, the irinotecan and bevacizumab will be given on days 1, 15 and 29.
Receives: Drug: bevacizumab; Drug: irinotecan; Procedure: dynamic contrast-enhanced magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS)

    Assessed by DCE-MRI

    Measured: 1 year

Secondary outcomes (2)

  1. Overall Survival and Tumor Response

    Measured: 2 years

  2. Incidence and severity of central nervous system (CNS) hemorrhage and systemic hemorrhage

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2006
  4. Study completionJul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00352521
Sponsor's protocol ID
Pro00012387
Other IDs
DUMC-8053-05-12R0, CDR0000481476
Status last verified
Feb 2013
First submitted
13 Jul 2006
Last updated
22 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, irinotecan and dynamic contrast-enhanced magnetic resonance imaging in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of the acute permeability and blood flow response (24-48 hours) with progression-free survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00352521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.

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