Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitogens

Iodine

Cadexomer iodine

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.

MAb-425

Luther W Brady, MD

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.

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.

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

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

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.

Drexel University College of Medicine

Glioblastoma

Astrocytoma

All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.

MAB-425 radiolabeled with I-125

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas

For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline

Drexel University

Luther W. Brady, M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas	NCT00589706	Gliomas	MAb-425	18 Years -	Drexel University
Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas	NCT01317888	Glioblastoma Mu... Astrocytoma Ana...	MAB-425 radiola...	18 Years -	Drexel University
A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas	NCT00589706	Gliomas	MAb-425	18 Years -	Drexel University

Spots Global Cancer Trial Database for high grade gliomas of the brain