AMP: Single arm, phase I/II study to evaluate the six month progression free survival of AMG 102 and panitumumab in recurrent Glioblastoma Multiforme (GBM)

niversity of Sydney0 个研究点目标入组 42 人开始时间: 2010年1月27日最近更新: 2020年1月13日

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•1. Patients must have clinically or histologically proven recurrent supratentorial glioblastoma (Astrocytoma World Health Organisation (WHO) Grade IV, including GBM subtypes, e.g. gliosarcoma).
•2. Measurable disease at either initial diagnosis or at recurrence.
•3. >=18 years of age;
•4. Tumour tissue specimens must be available;
•5. Stable or decreasing dose of steroids for >=7 days prior to registration;
•6. Patients must have had prior treatment with radiotherapy and temozolomide;
•7. Phase I: Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1; Phase II: ECOG Performance Status 0-2;
•8. Patients must have a mini-mental state examination (MMSE) of >=15;
•9. Adequate hepatic, renal and bone marrow function;
•10. Written informed consent must be obtained.

•1. Treatment with chemotherapy, biologic agents or anti-coagulants within 30 days prior to registration, or prior treatment with an anti-Epidermal Growth Factor Receptor (EGFR) agent at any time;
•2. Have had any surgery or brain biopsy within 4 weeks prior to registration or who have not fully recovered from this intervention;
•3. History of other malignancy;
•4. History of coagulation disorder associated with bleeding;
•5. Thrombosis or vascular ischemic events within one year prior to registration;
•6. Concurrent illness;
•7. Inability to undergo Gd-MRI;
•8. Clinically significant cardiovascular disease within one year prior to registration;
•9. History of interstitial lung disease.

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