Bevacizumab in Treating Patients With Recurrent or Progressive Glioma
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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 |
- 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 2013 |
| 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 |
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| 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 | |
| Principal Investigator: | Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center |
More Information
Publications:
| 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 21, 2013 |
| 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 May 16, 2013