- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00589706
A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas
May 8, 2017 updated by: Drexel University College of Medicine
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
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.
Study Overview
Detailed Description
This is an open-label Phase II study of postoperative radiation therapy followed by Iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125I-MAB 425) derived from cell cultures for high grade malignant gliomas.
Each subject will receive postoperative radiation therapy followed by 6.4 mg of 50 mCi labeled 125I-MAB 425 by injection.
This dosing regimen will be given three times generally within a two-week period (days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mCi labeled 125I-MAB 425 for each course of therapy.
The main objective of this study is to determine if the addition of 125I-MAB 425 to postoperative radiotherapy, with or without change, prolongs absolute survival compared to historical control (postoperative radiation therapy alone) in subjects with histologically proven high grade gliomas.
The primary efficacy variable is absolute survival and the secondary target variable will be time to progression of the tumor.
Multiple courses will be considered based on the subject's clinical status.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19102
- Hahneman Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all cases above 18 years of age
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
The purpose of this protocol is to allow you to receive course(s) of 1251-MAB 425 until your brain tumor begins to grow, you develop side effects to the treatment, or your medical condition changes (ie: become affected with human immunodeficiency virus (HIV) or develop another cancer).
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival
Time Frame: More than a year
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Potential benefits may include improved long-term survival.
All or part of your tumor may be destroyed.
You may experience relief of symptoms related to your tumor.
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More than a year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luther W Brady, MD, Drexel University College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1985
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Actual)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12555
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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