التفاصيل البيبلوغرافية
| العنوان: |
Stereotactic Injection of DTI-015 into Recurrent Malignant Gliomas: Phase I/II Trial |
| المؤلفون: |
Samuel J. Hassenbusch, Emilio M. Nardone, Victor A. Levin Y, Norman Leeds Z, Dennis Pietronigro X |
| المساهمون: |
The Pennsylvania State University CiteSeerX Archives |
| المصدر: |
http://www.neoplasia.com/pdf/manuscript/v05i01/neo02250.pdfTest. |
| المجموعة: |
CiteSeerX |
| مصطلحات موضوعية: |
stereotactic injection, malignant glioma, GBM, recurrent tumor, clinical trial |
| الوصف: |
DTI-015 (BCNU in 100 % ethanol) utilizes solvent facilitated perfusion for the intratumoral treatment of gliomas. The ethanol solvent vehicle facilitates a rapid and thorough saturation of the tumor with the dissolved anticancer agent BCNU. We conducted a phase I / II dose escalation study of DTI-015 in 40 heavily pretreated patients with inoperable recurrent malignant glioma. The study goals were to establish a maximally tolerated dose (MTD) for DTI-015 and assess its safety and activity. Patients received stereotactic intratumoral injection of DTI-015 under magnetic resonance imaging guidance. Dose escalation was performed in two phases. First, DTI-015 volume was escalated at a set BCNU concentration of 12.5 mg/ml; second, BCNU mg dose was escalated by increasing BCNU concentration to 30, 45, 60, and 75 mg/ml. A MTD of 5 ml and 240 mg was established. Twenty-five of 28 DTI-015 treatments (89%) using MTD were administered safely without producing high-grade drug-related adverse events. Me-dian survival for GBM patients administered DTI-015 at MTD was 55 weeks. Magnetic resonance imaging de-monstrated stable disease in 72 % of evaluable patients with a median of 10.5 weeks. The results suggest that DTI-015 administered at MTD is well tolerated and active in patients with inoperable recurrent GBM. |
| نوع الوثيقة: |
text |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.554.3360Test; http://www.neoplasia.com/pdf/manuscript/v05i01/neo02250.pdfTest |
| الإتاحة: |
http://www.neoplasia.com/pdf/manuscript/v05i01/neo02250.pdfTest |
| حقوق: |
Metadata may be used without restrictions as long as the oai identifier remains attached to it. |
| رقم الانضمام: |
edsbas.68A43D02 |
| قاعدة البيانات: |
BASE |
