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.
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
John Fiveash, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|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|