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

Completed · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID: NCT01268566
Run by: MedImmune LLC
People needed: 62
Starts: 2011-01-01
Expected to finish: 2012-11-01
Last updated by the study team: 2017-04-06

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Tucson, Arizona, United States
Research Site — Los Angeles, California, United States
Research Site — Stanford, California, United States
Research Site — Chicago, Illinois, United States
Research Site — Boston, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — New York, New York, United States
Research Site — Canton, Ohio, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Nashville, Tennessee, United States
Research Site — San Antonio, Texas, United States
Research Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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