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