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Brain/Spinal Cord Cancers

MEDI-575 for Recurrent Glioblastoma Multiforme (UW10053)
PhaseII Study of MEDI-575 in Adult Subjects with Recurrent Glioblastoma Multiforme
Status Conditions Phase Study ID
Closed Glioblastoma Multiforme Phase II 20110231

This is a Phase 2, multicenter, open-label, single-arm study to evaluate the antitumor activity, safety, and pharmacology of MEDI-575 in adult subjects with first recurrence of GBM.

Approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of MEDI-575 in the treatment of subjects with first recurrence of GBM. Subjects will receive MEDI-575 as a 60-minute IV infusion on Day 1 every 21 days until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for subject withdrawal.

The primary assessment of antitumor activity is PFS-6; tumor response and progression will be determined using Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group v.1. Approximately 15 investigational sites in the United States will participate in this study. All subjects will be followed every 3 months for the duration of the trial (defined as 9 months from the date the last subject is entered into the trial or when the sponsor stops the study.

Marc Chamberlain, MD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
July 25, 2012
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.