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Bevacizumab in Treating Patients With Recurrent Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290797
  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 high-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: bevacizumab
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Bevacizumab for Patients With Recurrent High-Grade Gliomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression free survival at 6 months [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radiographic response rate [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: January 2006
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor activity of bevacizumab, as determined by progression-free survival, in patients with recurrent high-grade glioma.
  • Determine the safety of bevacizumab in these patients.

Secondary

  • Estimate the objective radiographic response rate.
  • Correlate objective radiographic response rates with progression-free survival.
  • Evaluate the utility of serial MRI blood perfusion scans immediately prior to and after administration of bevacizumab as a tool to evaluate response.
  • Correlate changes in serial PET scans with progression-free survival.
  • Characterize pattern of changes in the number of endothelial progenitor cells over time and across patients.
  • Determine the effects of response to treatment (stable disease or radiographic response) on quality of life of these patients.

OUTLINE: This is an open-label study. Patients are stratified according to tumor type (glioblastoma multiforme or gliosarcoma vs anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma [not otherwise specified]).

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days for up to approximately 1 year in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at the baseline, prior to each course of study treatment, and then within 2 weeks after completion of study treatment.

After completion of study treatment, patients are followed within 2 weeks.

PROJECTED ACCRUAL: A total of 88 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 proven intracranial malignant glioma, including the following:

    • Glioblastoma multiforme
    • Gliosarcoma
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma not otherwise specified
  • Recurrent disease
  • Patients must have evidence of tumor progression by MRI or CT scan (performed within the past 14 days and while on a fixed dose of steroids for at least 5 days)

    • Progressive disease after radiation therapy
  • No evidence of acute intracranial/intratumoral hemorrhage

PATIENT CHARACTERISTICS:

  • Life expectancy > 8 weeks
  • Karnofsky performance status ≥ 60%
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • SGOT and bilirubin < 2 times upper limit of normal
  • Creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
  • No significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patients' ability to tolerate this therapy
  • No proteinuria by dipstick or urinalysis OR urine protein < 1,000 mg by 24-hour urine collection (for patients with proteinuria ≥ 1+ or urine protein:creatinine ratio > 1.0)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
  • No significant active cardiac, hepatic, renal, or psychiatric diseases
  • No other malignancy that has required treatment in the past 12 months or will require treatment in the next 12 months, except for nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No active infections
  • No disease that would obscure toxicity of the study drug
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • PT INR ≤1.5
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No clinically significant cardiovascular disease, including any of the following:

    • Cerebrovascular accident within the past 6 months
    • Uncontrolled hypertension (> 150/100 mm Hg)
    • Myocardial infarction or unstable angina within the past 6 months
    • New York Heart Association class II-IV congestive heart failure
    • Serious cardiac arrhythmia requiring medication
    • Unstable angina pectoris
    • Clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recent resection of recurrent or progressive tumor allowed provided patient has recovered from effects of surgery

    • Residual disease allowed, but not required
  • No radiation therapy within the past 4 weeks
  • Recovered from toxic effects of prior therapy
  • At least 2 weeks since prior investigational agent
  • At least 4 weeks since prior cytotoxic therapy
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 3 weeks since prior procarbazine
  • At least 1 week since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, and tretinoin)

    • Does not include radiosensitizers
  • No concurrent standard anticancer chemotherapy, investigational agents, radiotherapy, or immunotherapy
  • No other concurrent anticoagulation or antiplatelet medication, including aspirin, nonsteroidal anti-inflammatories, or cyclooxygenase-2 inhibitors
  • No major surgical procedure or open biopsy within the past 28 days
  • No core biopsy within the past 7 days
  • No major surgical procedures during the course of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290797

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Web site for additional information  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000465482, NCI-06-C-0064, NCI-P6762
Study First Received: February 9, 2006
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00290797  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
adult anaplastic astrocytoma
adult gliosarcoma
adult glioblastoma
adult mixed glioma
adult giant cell glioblastoma
recurrent adult brain tumor

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Bevacizumab
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Nervous System Diseases
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009