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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC

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