This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Northwestern University
Collaborator National Cancer Institute (NCI)
Start date March 2006
End date November 2008
Trial size 55 participants
Trial identifier NCT00337207, NU 05C3, NU-05C3, STU00005237


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.

Primary Outcomes

Safety of Treatment
time frame: Throughout treatment and up to 30 days post-treatment
Progression-free Survival at 6 Months
time frame: After all patients have surpassed the 6 month post-treatment timepoint
Tumoral Blood Flow Changes
time frame: Before and after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas
Principal investigator Jeffrey J. Raizer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Northwestern University.