Radiosurgery and Avastin for Recurrent Malignant Gliomas

NCT01017250 | Completed Results

• 1 other identifier: Pro00018943
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Malignant Glioma

Keywords

Recurrent

Outcome Measures

Primary Outcomes (1)

• Central Nervous System (CNS) Toxicity

  Number of participants who experience Grade 3 or higher adverse events in the "Nervous System Disorder" domain of Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.

  2 months after Stereotactic Radiosurgery

Secondary Outcomes (16)

• Progression-free Survival (PFS)

  1 year

• Radiographic Response at Month 2

  2 months after SRS

• Overall Survival(OS)

  2 years

• Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)

  2 months after SRS

• Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)

  2 months after SRS

Study Arms (1)

Stereotactic Radiosurgery

EXPERIMENTAL

Avastin and Radiosurgery

Radiation: Stereotactic Radiosurgery (SRS); Drug: Bevacizumab

Interventions

Stereotactic Radiosurgery (SRS) 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

Stereotactic Radiosurgery

Bevacizumab DRUG

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

Also known as: Avastin

Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Duke University Medical Center, Radiation Oncology

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioma; Recurrence

Interventions

Radiosurgery; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John Kirkpatrick, MD, PhD
• Organization: Duke University Radiation Oncology

robert.clough@dm.duke.edu

919 668-7342

Study Officials

• John Kirkpatrick, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 28, 2014
• Results First Posted: May 9, 2012

Record last verified: 2014-01

Locations

US (1)