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Brain and Central Nervous System TumorsPhase 2NCT00268359

Bevacizumab and Irinotecan in Treating Patients With Recurrent or Refractory Gliomas

A Phase 2 study testing bevacizumab and irinotecan hydrochloride 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. 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 and irinotecan hydrochloride
How many people
68 participants
Where
1 siteUnited States
Study dates
May 2005to Oct 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:

  • 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

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: 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 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.

Read the 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.

Keywords
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult giant cell glioblastoma
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

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

What is being measured

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

  1. Safety

  2. Activity in terms of progression-free survival

Timeline

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

  1. First posted22 Dec 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2006
  4. Study completionOct 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
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268359
Sponsor's protocol ID
Pro00004091
Other IDs
DUMC-6771-05-1R0, GENENTECH-AVF3311s, CDR0000450832
Status last verified
Feb 2013
First submitted
20 Dec 2005
Last updated
21 Jul 2014
Results posted
No

Publications

  • Desjardins A, Reardon DA, Herndon JE 2nd, Marcello J, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Sampson J, Bailey L, Bigner DD, Friedman AH, Friedman HS, Vredenburgh JJ. Bevacizumab plus irinotecan in recurrent WHO grade 3 malignant gliomas. Clin Cancer Res. 2008 Nov 1;14(21):7068-73. doi: 10.1158/1078-0432.CCR-08-0260.

    PubMed 18981004

  • Sathornsumetee S, Cao Y, Marcello JE, Herndon JE 2nd, McLendon RE, Desjardins A, Friedman HS, Dewhirst MW, Vredenburgh JJ, Rich JN. Tumor angiogenic and hypoxic profiles predict radiographic response and survival in malignant astrocytoma patients treated with bevacizumab and irinotecan. J Clin Oncol. 2008 Jan 10;26(2):271-8. doi: 10.1200/JCO.2007.13.3652.

    PubMed 18182667

  • Vredenburgh JJ, Desjardins A, Herndon JE 2nd, Dowell JM, Reardon DA, Quinn JA, Rich JN, Sathornsumetee S, Gururangan S, Wagner M, Bigner DD, Friedman AH, Friedman HS. Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma. Clin Cancer Res. 2007 Feb 15;13(4):1253-9. doi: 10.1158/1078-0432.CCR-06-2309.

    PubMed 17317837

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and irinotecan hydrochloride 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 21 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?

Safety. The study lists 2 primary outcomes in all. 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 NCT00268359, which also lists 3 linked publications.

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 21 Jul 2014.

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