A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00589706
First received: December 26, 2007
Last updated: June 15, 2010
Last verified: December 2007
  Purpose

data from the wistar institute indicated that this anti-body labeled with iodine-125 would localized in the tumor cells of high grade gliomas of the brain. the project combines surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II trial in this disease entity.


Condition Intervention Phase
Gliomas
Drug: MAb-425
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 II Study o the Adjuvant Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFR-425) Monoclonal Antibody Radiolabeled With I-125 for High Grade Gliomas

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • survival [ Time Frame: more than a year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: January 1985
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
Drug: MAb-425
MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
Drug: MAb-425
All patient receive MAb-425 along with Iodine-125 as an injection for a total of three treatments.Each treatment is separated by one week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all cases above 18 years of age

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589706

Locations
United States, Pennsylvania
Hahneman Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
  More Information

No publications provided by Drexel University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: luther w. brady, md, ducom
ClinicalTrials.gov Identifier: NCT00589706     History of Changes
Other Study ID Numbers: 12555
Study First Received: December 26, 2007
Last Updated: June 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Drexel University:
high grade gliomas of the brain
anti-body treatment
survival

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antibodies, Monoclonal
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014