Radiosurgery and Avastin for Recurrent Malignant Gliomas

NCT ID: NCT01017250

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-02-29

Brief Summary

The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).

Detailed Description

In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm in maximum dimension no longer responding to conventional chemotherapy but able to tolerate further chemotherapy will be enrolled. The primary endpoint of this study will be the proportion of patients who experience CNS toxicity, with secondary endpoints progression-free survival, overall survival, steroid dosage, development of radionecrosis, quality of life, objective radiographic response and performance status.

Conditions

Malignant Glioma

Study Design

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

Study Groups

Stereotactic Radiosurgery

Avastin and Radiosurgery

Group Type: EXPERIMENTAL

Stereotactic Radiosurgery (SRS)

Intervention Type: RADIATION

Tumor Volume \< 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction

Bevacizumab

Intervention Type: DRUG

Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS

Interventions

Stereotactic Radiosurgery (SRS)

Tumor Volume \< 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction

Intervention Type: RADIATION

Bevacizumab

Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility Criteria

Inclusion Criteria

• History of malignant glioma (WHO Grade III or IV) of the brain treated with some combination of surgery, biochemotherapy and conventionally fractionated external beam radiotherapy
• Radiotherapy completed at least 6 months prior to recurrence
• Age 18 years and older
• New or enlarging contrast-enhancing and/or 18FDG-avid nodule, at least 1 cm diameter
• Estimated life expectancy of 3 months or longer

Exclusion Criteria

• Avastin therapy within 21 days of start of participation
• Contraindication to Avastin therapy or brain MRI
• Presence of bleeding diathesis or coagulopathy
• History of prior arterial thrombotic event, myocardial infarction, angina, CVA, TIA, CABG angioplasty or stenting within 6 months.
• Inadequately controlled hypertension (defined as systolic blood pressure
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• Clinically significant vascular disease
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to onset of treatment
• Prior history of hypertensive crisis or hypertensive encephalopathy
• History of abdominal fistula or GI perforation within 6 months prior to onset of treatment
• Serious non-healing wound, active ulcer or untreated bone fracture
• Proteinuria demonstrated by Urine Protein Creatinine ratio > 1.0
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Kirkpatrick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center, Radiation Oncology

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00018943

Identifier Type: -

Identifier Source: org_study_id