Clinical trial NCT01017250: Radiosurgery and Avastin for Recurrent Malignant Gliomas
Official title: Radiosurgery and Avastin for Recurrent Malignant Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Glioma
Keywords: Recurrent
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Central Nervous System (CNS) Toxicity
timeFrame: 2 months after Stereotactic Radiosurgery
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 1 year
measure: Radiographic Response at Month 2
timeFrame: 2 months after SRS
measure: Overall Survival(OS)
timeFrame: 2 years
measure: Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS)
timeFrame: 2 months after SRS
measure: Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE)
timeFrame: 2 months after SRS
measure: Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT)
timeFrame: 2 months after SRS
measure: Performance Status at 2 Months After Stereotactic Radiosurgery (SRS)
timeFrame: 2 months after SRS
measure: Steroid Usage After Stereotactic Radiosurgery (SRS)
timeFrame: 2 months after SRS 2 months after SRS 2 months after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans
timeFrame: 1 week after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans
timeFrame: 2 months after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC
timeFrame: 1 week after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC
timeFrame: 2 months after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF
timeFrame: 1 week after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF
timeFrame: 2 months after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC
timeFrame: 1 week after SRS
measure: Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC
timeFrame: 2 months after SRS
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Radiation Oncology
state: North Carolina
Study officials:
affiliation: Duke University
name: John Kirkpatrick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: