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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01268566
First received: December 29, 2010
Last updated: March 14, 2014
Last verified: March 2014
  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.


Condition Intervention Phase
Glioblastoma Multiforme
Drug: MEDI-575
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Evaluate the progression free survival at 6 months in subjects with a recurrence of Glioblastoma Multiforme [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess Medi-575 activity, safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    1) To evaluate other antitumor activities of MEDI-575 2) To describe the safety and tolerability of MEDI-575 3) To determine the expression of PDGFRα in the tumor cells of archived tumor samples


Enrollment: 62
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-575 treatment
MEDI-575 treatment
Drug: MEDI-575
MEDI-575 as an IV infusion.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268566

Locations
United States, Arizona
Research Site
Tucson, Arizona, United States
United States, California
Research Site
Los Angeles, California, United States
Research Site
Stanford, California, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, New York
Research Site
New York, New York, United States
United States, Ohio
Research Site
Canton, Ohio, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
San Antonio, Texas, United States
United States, Washington
Research Site
Seattle, Washington, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Naimish Pandya, M.D. MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01268566     History of Changes
Other Study ID Numbers: CD-ON-MEDI-575-1042
Study First Received: December 29, 2010
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Glioblastoma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on September 18, 2014