Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.
PhasePhase 1/Phase 2
StatusCompleted No Results Posted
Indication/ConditionGlioma Brain Neoplasm
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.
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.
Patient must have given informed consent Patient must have histologically confirmed supratentorial malignant glioma Patients must have recovered from toxicity of prior therapy Patients must be eligble for resection of the recurrent tumor