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Brain and Central Nervous System TumorsPhase 2NCT00337207

Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

A Phase 2 study testing bevacizumab in people with Brain and Central Nervous System Tumors, run by Northwestern University at 2 sites 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesUnited States
Study dates
Mar 2006to May 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 malignant glioma, including the following:
  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic astrocytoma or anaplastic glioma
  • Malignant glioma not otherwise specified
  • Evidence of tumor recurrence or progression by MRI or CT scan with contrast
  • CT scan or MRI must be performed ≤ 96 hours post-operatively (≤ 2 weeks prior to study registration) or 4-6 weeks post-operatively to assess residual disease in patients who have undergone recent resection of recurrent or progressive tumor
  • Steroid dosage must have been stable for ≥ 5 days
  • Failed ≥ 1 prior systemic treatment with chemotherapy or biologic agents (excluding polifeprosan 20 with carmustine implant [Gliadel wafers])
  • Failed prior external-beam radiotherapy
  • If received prior interstitial brachytherapy or stereotactic radiosurgery, true progressive disease (rather than radiation necrosis) must be confirmed by positron emission tomography, single-photon emission computer tomography with thallium, magnetic resonance (MR) spectroscopy, MR perfusion, or surgical documentation

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy > 8 weeks
  • WBC > 3,000/mm³
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 10 g/dL (transfusion allowed)
  • SGOT and SGPT < 1.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Creatinine < 1.5 mg/dL
  • Blood pressure ≤ 150/100 mm Hg
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No stroke or myocardial infarction within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • Urine protein:creatinine ratio < 1.0
  • No significant medical illness that would preclude study participation or cannot be adequately controlled with appropriate therapy
  • No other serious medical illness or infection
  • No disease that would obscure toxicity or dangerously alter drug metabolism
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless cancer is in complete remission and patient is off all therapy for that cancer for ≥ 3 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior surgery for recurrent or progressive disease and recovered
  • More than 28 days since prior major surgical procedure or open biopsy
  • At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)
  • At least 2 weeks since prior vincristine
  • At least 3 weeks since prior procarbazine hydrochloride
  • At least 1 week since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)
  • Radiosensitizer does not count
  • At least 4 weeks since prior experimental biologic agents (e.g., epidermal growth factor receptor [EGFR] inhibitors)
  • More than 7 days since prior minor surgery, such as fine-needle aspirations or core biopsies
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent enzyme-inducing anticonvulsants (EIACs)
  • Patients on EIACs must switch to nonenzyme-inducing convulsants ≥ 2 weeks prior to study enrollment

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Hematology-Oncology Associates of Illinois

    Chicago, Illinois, 60611-2998

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

Other trials in United States

About this study

Official title: A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive 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.

PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.

Read the detailed description

OBJECTIVES:

  • Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma.
  • Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients.
  • Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy.

OUTLINE: This is a pilot study.

Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

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

What participants receive

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

  • bevacizumabBiological

    Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.

Study groups in NCT00337207
Study groupRoleWhat they receive
AvastinExperimentalNot described
Receives: Biological: bevacizumab

What is being measured

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

  1. Safety of Treatment

    Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

    Measured: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.

  2. Progression-free Survival at 6 Months

    The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.

    Measured: After all patients have surpassed the 6 month post-treatment timepoint

  3. Tumoral Blood Flow Changes

    To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.

    Measured: Before and after treatment

Timeline

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

  1. First posted15 Jun 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionNov 2008
  4. Study completionMay 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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00337207
Sponsor's protocol ID
NU 05C3
Other IDs
NU-05C3, STU00005237
Status last verified
Jan 2020
First submitted
13 Jun 2006
Last updated
7 Feb 2020
Data monitoring committee
Yes

Publications

  • Raizer JJ, Gallot L, Cohn R, et al.: A phase II safety study of bevacizumab in patients with multiple recurrent or progressive malignant gliomas. [Abstract] J Clin Oncol 25 (Suppl 18): A-2079, 94s, 2007.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab in people with Brain and Central Nervous System Tumors, run by Northwestern University at 2 sites 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of Treatment (time frame: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.). The study lists 3 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 NCT00337207, which also lists 1 linked publication.

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 7 Feb 2020.

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