Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.|
|Study Start Date:||June 2002|
|Estimated Study Completion Date:||August 2003|
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.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3295|
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010-3000|
|United States, Missouri|
|Saint Louis University|
|St. Louis, Missouri, United States, 63110-0250|
|Study Director:||Diana M Hablitz, MSNCRNP||TransMolecular|