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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
NCT01268566
Summary

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.


Investigator
Marc Chamberlain, MD
Location    
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 ClinicalTrials.gov
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.