A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme

Inclusion Criteria:

• Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
• Age ≥18 years old at the time of screening
• Histologically confirmed diagnosis of World Health Organization Grade IV malignant glioma (glioblastoma or gliosarcoma)
• Previous first line treatment with radiotherapy and temozolomide (treatment prior to radiation and temozolomide permitted, [ie, Gliadel])
• Documented first recurrence of GBM by diagnostic biopsy or by contrast-enhanced magnetic resonance imaging (MRI) as per Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (Wen et al, 2010)
• Life expectancy ≥ 12 weeks
• Adequate hematologic and organ function
• Negative serum pregnancy test (women only)
• Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential

Exclusion Criteria:

• Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, hormonal therapy or investigational agent 30 days prior to study entry
• Concurrent enrollment in another clinical study involving an investigational agent
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• Previous mAb treatment specifically directed against PDGF or PDGF receptors
• Previous bevacizumab or other VEGF and anti-angiogenic treatment
• More than 1 recurrence of GBM
• Any surgery (not including minor diagnostic procedures) within 2 weeks prior to baseline disease assessments; or not fully recovered from any side effects of previous procedures
• History of serious allergy or reaction to any component of the MEDI-575 formulation
• New York Heart Association ≥ Grade 2 congestive heart failure within 6 months prior to study entry
• Uncontrolled or significant cardiovascular disease
• History of other invasive malignancy within 5 years prior to study entry except for cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that have been surgically cured
• History of active human immunodeficiency virus or active hepatitis B or C viral infection will be excluded to eliminate the risk of increased AEs due to immune compromise.
• Systemic immunosuppressive therapy.
• Subjects taking corticosteroids must be on a stable dose for 7 days prior to initiation of treatment with MEDI-575 16) Presence of extracranial metastatic or leptomeningeal disease