Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

MedImmune LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: MEDI-575

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 95 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting