A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.
This is an open label single-dose study to be conducted in 18 evaluable patients with
recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access
device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma
includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and
gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be
administered using a dose escalating scheme.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Diana M Hablitz, MSNCRNP
United States: Food and Drug Administration
|City of Hope||Duarte, California 91010|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|
|Saint Louis University||St. Louis, Missouri 63104|