Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

NCT00337207 | Completed Phase 2 Results DMC

• 3 other identifiers: NU 05C3NU-05C3STU00005237
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult gliosarcoma; recurrent adult brain tumor; adult anaplastic astrocytoma; adult giant cell glioblastoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Avastin

EXPERIMENTAL

Biological: bevacizumab

Interventions

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.

Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma; Brain Neoplasms; Astrocytoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Research Office Administrator
• Organization: Northwestern University

cancertrials@northwestern.edu

312-695-1301

Study Officials

• Jeffrey J. Raizer, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffrey Raizer, MD

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: March 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 7, 2020
• Results First Posted: November 19, 2012

Record last verified: 2020-01

Locations

US (2)