Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Raizer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00337207
First received: June 13, 2006
Last updated: March 31, 2014
Last verified: March 2014
  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 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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Safety of Treatment [ Time Frame: Throughout treatment and up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
  • Progression-free Survival at 6 Months [ Time Frame: After all patients have surpassed the 6 month post-treatment timepoint ] [ Designated as safety issue: No ]
    The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.

  • Tumoral Blood Flow Changes [ Time Frame: Before and after treatment ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: March 2006
Estimated Study Completion Date: December 2016
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin Biological: bevacizumab
Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337207

Locations
United States, Illinois
Hematology-Oncology Associates of Illinois
Chicago, Illinois, United States, 60611-2998
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
  More Information

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.

Responsible Party: Jeffrey Raizer, Jeffrey Raizer, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00337207     History of Changes
Other Study ID Numbers: NU 05C3, NU-05C3, STU00005237
Study First Received: June 13, 2006
Results First Received: October 21, 2012
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
United States: Northwestern University Institutional Review Board

Keywords provided by Northwestern University:
adult glioblastoma
adult gliosarcoma
recurrent adult brain tumor
adult anaplastic astrocytoma
adult giant cell glioblastoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014