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| ID | Type | Description | Link |
|---|---|---|---|
| NU-05C3 | Other Identifier | Northwestern University Cancer Center | |
| STU00005237 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year. |
| Progression-free Survival at 6 Months | The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point. | After all patients have surpassed the 6 month post-treatment timepoint |
| Tumoral Blood Flow Changes | To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy. | Before and after treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma, including the following:
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
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:
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)
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)
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J. Raizer, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology Associates of Illinois | Chicago | Illinois | 60611-2998 | United States | ||
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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Patients were recruited from the Neuro-Oncology outpatient clinic and inpatient services between the dates of March 16, 2006 and June 5, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Treatment | All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Treatment | All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All patients that receive at least one dose of study treatment are evaluable for toxicity | Posted | Number | participants | From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year. |
|
From time of first study treatment up to 30 days after the last dose (total time frame was variable by patient).
All patients were evaluable for toxicity from the time of their first treatment with bevacizumab. Patients continued on treatment until disease progression or unacceptable toxicity, thus the evaluation period was different for each patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Treatment | All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage - GI (rectal) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Office Administrator | Northwestern University | 312-695-1301 | cancertrials@northwestern.edu |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D001932 | Brain Neoplasms |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Patients with histologically proven malignant gliomas were eligible to be enrolled including the following diagnoses: glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendronglioma, anaplastic mixed glioma or malignant glioma NOS (not otherwise specified). | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Progression-free Survival at 6 Months | The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point. | 1 patient became deceased due to toxicity prior to the 6 month time point and thus, was not evaluable for the 6 month progression free survival endpoint. | Posted | Number | Participants | After all patients have surpassed the 6 month post-treatment timepoint |
|
|
|
| Primary | Tumoral Blood Flow Changes | To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy. | This was an optional outcome measure. Data was not collected or analyzed for this outcome measure. | Posted | Before and after treatment |
|
|
| 9 |
| 55 |
| 55 |
| 55 |
| Perforation - GI (bowel) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis/embolism (venous) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Death due to disease progression | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Personality/behavioral | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated transaminases - AST/ALT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal - Other (hematuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D005910 |
| Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |