Radiosurgery and Avastin for Recurrent Malignant Gliomas
This study has been completed.
Sponsor:
Duke University
Collaborator:
Genentech
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01017250
First received: November 19, 2009
Last updated: May 29, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Malignant Glioma |
Radiation: Stereotactic Radiosurgery (SRS) Drug: Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Radiosurgery and Avastin for Recurrent Malignant Gliomas |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- Central Nervous System (CNS) Toxicity [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]Grade 3 or higher adverse event in the "Nervous System Disorder" domain of CTCAE v4.0. CNS hemorrhage is the primary toxicity to assess.
Secondary Outcome Measures:
- Progression-free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Radiographic Response [ Time Frame: 2 months ] [ Designated as safety issue: No ]Radiographic response by magnetic resonance imaging (MRI)
| Enrollment: | 15 |
| Study Start Date: | December 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stereotactic Radiosurgery
Avastin and Radiosurgery
|
Radiation: 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
Drug: Bevacizumab
Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS
Other Name: Avastin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017250
Locations
| United States, North Carolina | |
| Duke University Medical Center, Radiation Oncology | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Genentech
Investigators
| Principal Investigator: | John Kirkpatrick, MD, PhD | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01017250 History of Changes |
| Other Study ID Numbers: | Pro00018943 |
| Study First Received: | November 19, 2009 |
| Results First Received: | April 11, 2012 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Recurrent |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Bevacizumab |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013