Trial | NCT00040573  Report issue

Title

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.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
Study Started
Jun 30
2002
Study Completion
Aug 31
2003
Last Update
Mar 31
2009
Estimate

Drug 131I-TM-601

Criteria 

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
No Results Posted