A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
This phase II trial was designed in two sequences. The first sequence, which is now
complete to accrual was an open-label, dose escalation, multi-dose study and treated 12
evaluable patients with high-grade glioma.
The second sequence is currently open and accruing eligible subjects with high-grade glioma.
The trial is an open-label, randomized study and will accrue a total of 54 evaluable
patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I
labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first
sequence of the trial. Patients will undergo debulking surgery and placement of a
ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients
who participated in the first sequence are not eligible to participate in the second
sequence of the study.
High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma,
oligoastrocytoma or gliosarcoma.
Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI)
assessments, at defined intervals, until 12 months after the first study dose.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
28 days post last dose
Yes
John Fiveash, MD
Principal Investigator
University of Alabama at Birmingham
United States: Food and Drug Administration
TM-601-002
NCT00114309
November 2004
August 2009
Name | Location |
---|---|
Henry Ford Hospital | Detroit, Michigan 48202 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
Washington University Medical Center | Saint Louis, Missouri 63105 |
University of Washington | Seattle, Washington 98195 |
City of Hope | Duarte, California 91010 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Northwestern University | Chicago, Illinois 60611 |
Emory University | Atlanta, Georgia 30322 |
University of Chicago | Chicago, Illinois 60637 |
Moffitt Cancer Center | Tampa, Florida 33612 |
Johns Hopkins Medical Center | Baltimore, Maryland |
Columbia University Medical Center | New York, New York 10032 |
Tufts-New England Medical Center | Boston, Massachusetts 02111 |
Lacks Cancer Center at St. Mary's Health Care | Grand Rapids, Michigan 49503 |
St. Louis Hospital | St. Louis, Missouri 63110 |
Carolina Neurosurgery and Spine | Charlotte, North Carolina 28204 |