N/A
N=15
Radiosurgery and Avastin for Recurrent Malignant Gliomas
Malignant Glioma
Bottom Line
View on ClinicalTrials.gov: NCT01017250 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
May 2012
Primary outcome: Primary: Central Nervous System (CNS) Toxicity — 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Radiosurgery (SRS) (Radiation); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Nervous System (CNS) Toxicity |
1 | — |
| SECONDARY Progression-free Survival (PFS) |
3.9 | — |
| SECONDARY Radiographic Response at Month 2 |
0; 0; 10; 4; 1 | — |
| SECONDARY Overall Survival(OS) |
14.4 | — |
| SECONDARY Change in Quality of Life From Baseline to 2 Months After Stereotactic Radiosurgery (SRS) |
-2.9; -0.1; -0.4; -1.2; -4.6; 0.8 | — |
| SECONDARY Cognition at 2 Months After Stereotactic Radiosurgery (SRS)as Measured by the Mini-Mental State Exam ( MMSE) |
0.3 | — |
| SECONDARY Cognition at 2 Months After Stereotactic Radiosurgery (SRS) as Measured by the Trail Making Test (TMT) |
0.6; -15.5 | — |
| SECONDARY Performance Status at 2 Months After Stereotactic Radiosurgery (SRS) |
11 | — |
| SECONDARY Steroid Usage After Stereotactic Radiosurgery (SRS) |
2; 4 | — |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): K-trans |
6.7; 4.1 | 0.04 sig |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): K-trans |
6.7; 0 | 0.002 sig |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): AUC |
2.1; 1.4 | 0.02 sig |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): AUC |
2.1; 0.1 | 0.0005 sig |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): EVF |
0.58; 0.48 | 0.53 |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): EVF |
0.58; 0 | 0.002 sig |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 1 Week After Stereotactic Radiosurgery (SRS): ADC |
980; 980 | 0.76 |
| SECONDARY Dynamic Contrasted-enhanced MRI (DCE-MRI) Perfusion Indices at 2 Months After Stereotactic Radiosurgery (SRS): ADC |
980; 990 | 0.34 |
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).
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
Data sourced from ClinicalTrials.gov (NCT01017250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.