Radiosurgery and Avastin for Recurrent Malignant Gliomas

Duke University

Status: Completed

Conditions: Malignant Glioma

Treatments: Drug: Bevacizumab; Radiation: Stereotactic Radiosurgery (SRS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01017250

Pro00018943

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Stereotactic Radiosurgery

Experimental group

Description:

Avastin and Radiosurgery

Treatment:

Radiation: Stereotactic Radiosurgery (SRS)

Drug: Bevacizumab