A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.
18 Years
N/A
Both
Glioma, Brain Neoplasm
Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Diana M Hablitz, MSNCRNP
Investigator Role:
Study Director
Investigator Affiliation:
TransMolecular
Authority:
United States: Food and Drug Administration
Study ID:
TM601-001
NCT ID:
NCT00040573
Start Date:
June 2002
Completion Date:
August 2003
Related Keywords:
- Glioma
- Brain Neoplasm
- Brain neoplasm
- Clinical trial, phase I/II
- Brain Neoplasms
- Neoplasms
- Glioma
Name | Location |
|---|---|
| City of Hope | Duarte, California 91010 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Saint Louis University | St. Louis, Missouri 63104 |
