Expired Study
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Philadelphia, Pennsylvania 19102


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.


Study summary:

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.


Criteria:

Inclusion Criteria: - all cases above 18 years of age Exclusion Criteria:


NCT ID:

NCT00589706


Primary Contact:

Principal Investigator
Luther W Brady, MD
Drexel University College of Medicine


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19102
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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