A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme
Trial ID or NCT#
NCT01268566
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme
Eligibility Criteria
Ages Eligible for Study: 18 Years to 95 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Lawrence Recht, MD
Neuro-oncologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
