A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

Summary

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.

Conditions

• Malignant Glioma
• Glioblastoma Multiforme
• GBM
• Astrocytoma
• Oligodendroglioma

Interventions

DRUG

131I-TM601

In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.

Sponsors & Collaborators

• TransMolecular

  lead INDUSTRY

Principal Investigators

• Karen Fink, MD · Baylor Health Care System

• Adam Mamelak, MD · Cedars-Sinai Medical Center

• Steven Rosenfeld, MD · Columbia University

• Jan Drappatz, MD · Dana-Farber Cancer Institute

• Patrick Wen, MD · Dana-Farber Cancer Institute

• Jeffrey Olson, MD · Emory University

• Richard Wahl, MD · Johns Hopkins University

• Heather Jacene, MD · Johns Hopkins University

• Antonio Omuro, MD · Memorial Sloan Kettering Cancer Center

• Edward Pan, MD · Moffitt Cancer Center

• Sean Grimm, MD · Northwestern University

• Jeffrey Raizer, MD · Northwestern University

• Nimish Mobile, MD · University of Rochester

• Marc Chamberlain, MD · University of Washington

• Jay-Jiguang Zhu, MD · Tufts Medical Center

• John Fiveash, MD · University of Alabama at Birmingham

• David Schiff, MD · University of Virginia

• Michael Edgeworth, MD · Vanderbilt University

• Mark Malkin, MD · Medical College of Wisconsin

• Maciej Mrugala, MD · University of Washington

• Steven Chmura, MD · University of Chicago

• Thomas Gribbin, MD · St. Mary's Health Care

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2010-02-28

Completion

2010-04-30

Countries

• United States

Study Locations