Bevacizumab in Treating Patients With Recurrent or Progressive Glioma

Northwestern University

Status and phase

Completed

Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Biological: bevacizumab

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00337207

NU 05C3

STU00005237 (Other Identifier)

NU-05C3 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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