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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gliomas Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hahneman Hospital

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all cases above 18 years of age

Exclusion criteria

Treatment and study plan

MAb-425

Drug

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.

Primary outcomes

Survival

Time frame: More than a year

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.

Sponsors and collaborators

Lead sponsor

Drexel University College of Medicine

Other

Registry information

Official study 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

Important dates

Study start: 1985
Primary completion: 2012
Study completion: 2012
First posted: Jan 10, 2008
Registry last updated: May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed