A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: MEDI-575
Intervention description: MEDI-575 as an IV infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Glioblastoma

Summary:

      The primary objective of this Phase II study is to evaluate the progression-free survival at
      6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated
      with MEDI-575.
    

Eligibility criteria:

        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