Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

NCT ID: NCT00337207

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-05-31

Brief 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. 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.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avastin

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Raizer

Jeffrey Raizer, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey J. Raizer, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

Hematology-Oncology Associates of Illinois

Chicago, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

NU-05C3

Identifier Type: OTHER

Identifier Source: secondary_id

STU00005237

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05C3

Identifier Type: -

Identifier Source: org_study_id